TEMPO 451514H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10705032008464), received between Jul 22, 2021 and Aug 14, 2026 — classified as 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Degraded” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252364 ↗
• MalfunctionApr 17, 2026Crack

  AS REPORTED, A 5F 100CM 135-DEGREE VERTEBRAL (VER) TEMPO DIAGNOSTIC CATHETER CRACKED. A SECOND 5F 100CM 135-DEGREE VER TEMPO DIAGNOSTIC CATHETER WAS USED AS A REPLACEMENT WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT OR ADVERSE EFFECTS NOTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916509 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 5F TEMPO VERTEBRAL (VERT) 100 CM DIAGNOSTIC CATHETER WAS FOUND BROKEN IN THE PATIENT¿S DISTAL INTERNAL CAROTID ARTERY (ICA) DURING MID-USE. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUEING WAS REQUIRED, AND NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE; HOWEVER, THE DISTAL TIP BROKE, AND ALTHOUGH THERE WAS NO KINK IN THE AREA OF SEPARATION, THE USER HAD TO SNARE IT OUT WITH DIFFICULTY. THE EVENT OCCURRED DURING A DIAGNOSTIC CEREBRAL ANGIOGRAM; THE VESSEL WAS NOT TORTUOUS AND THE CATHETER WAS NOT KINKED. THE LESION WAS NOT CALCIFIED, AND THE DEVICE WAS USED FOR A DIAGNOSTIC CEREBRAL ANGIOGRAM. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PATIENT REMAINED STABLE, THOUGH THE PROCESS WAS PROLONGED DUE TO RETRIEVAL DIFFICULTY. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS PROPERLY STORED AND OPENED IN A STERILE FIELD. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WI

  Patient problems: Foreign Body In Patient

  MAUDE report 24428031 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL END OF A 5F TEMPO VERTEBRAL (VERT) 100CM ANGIOGRAPHIC CATHETER WAS MISSING DURING PREPARATION FOR USE, AND THE DETACHED SEGMENT COULD NOT BE LOCATED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE, WHICH EXTENDED THE OPERATION TIME. THERE WAS NO REPORTED PATIENT INJURY. THE HOSPITAL REPORTED THE EVENT AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691585 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513253 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511097 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509836 ↗
• MalfunctionNov 9, 2025Crack; Crack

  AS REPORTED, A CRACK WAS PRESENT ON THE HUB OF A 5F VER 135° 100CM TEMPO DIAGNOSTIC CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO THE CHINA NMPA. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507087 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478629 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478553 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478519 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478493 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475636 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN USING A 5F 100CM 135-DEGREE VERTEBRAL (VERT) TEMPO DIAGNOSTIC CATHETER TO PERFORM A 3CC ANGIOGRAM OF THE AORTIC ARCH, THE TIP END OF THE DEVICE WAS FOUND DISLODGED. THE ANGIOGRAM WAS PERFORMED WITH A SYRINGE AND THE DISTAL TIP HAD DISLODGED WITHIN THE AORTIC ARCH. THE DISLODGED TIP WAS REMOVED WITH AN UNKNOWN SNARING DEVICE IN CONJUNCTION WITH A SURGICAL INCISION MADE AT THE FEMORAL ARTERY. THE PROCEDURE WAS CONCLUDED AFTER THE REMOVAL OF THE DISTAL TIP. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES INSERTING THE DEVICE INTO THE PATIENT PRIOR TO PERFORMING THE ANGIOGRAM. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438389 ↗
• MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. PICTURES WERE PROVIDED FOR REVIEW. THE PICTURES WERE REVIEWED AND APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF THE ANOMALIES OBSERVED, EITHER INSIDE OR OUTSIDE THE PACKAGING COULD NOT BE DETERMINED ON THE PICTURES PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292947 ↗
• MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. PICTURES WERE PROVIDED FOR REVIEW. THE PICTURES WERE REVIEWED AND APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF THE ANOMALIES OBSERVED, EITHER INSIDE OR OUTSIDE THE PACKAGING COULD NOT BE DETERMINED ON THE PICTURES PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292694 ↗
• MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. PICTURES WERE PROVIDED FOR REVIEW. THE PICTURES WERE REVIEWED AND APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF THE ANOMALIES OBSERVED, EITHER INSIDE OR OUTSIDE THE PACKAGING COULD NOT BE DETERMINED ON THE PICTURES PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292506 ↗
• MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. PICTURES WERE PROVIDED FOR REVIEW. THE PICTURES WERE REVIEWED AND APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF THE ANOMALIES OBSERVED, EITHER INSIDE OR OUTSIDE THE PACKAGING COULD NOT BE DETERMINED ON THE PICTURES PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291677 ↗
• MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. PICTURES WERE PROVIDED FOR REVIEW. THE PICTURES WERE REVIEWED AND APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF THE ANOMALIES OBSERVED, EITHER INSIDE OR OUTSIDE THE PACKAGING COULD NOT BE DETERMINED ON THE PICTURES PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291455 ↗
• MalfunctionSep 6, 2024Crack; Crack

  AS REPORTED, THE END OF THE 5F 100 CM TEMPO VERTEBRAL (VERT) CATHETER WAS FOUND BROKEN AND CHIPPED WHEN THE INSTRUMENTATION NURSE OPENED THE CONTRAST CATHETER DURING THE PROCEDURE AND ANOTHER TEMPO CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THREE (3) PICTURES WERE RECEIVED FOR REVIEW. TWO OF THEM SHOW THE PACKAGE LABELING. THE THIRD IMAGE SHOWS A LUER HUB, WHICH APPEARS TO HAVE A SPLINTERED CONDITION ON THE PROXIMAL SIDE OF THE COMPONENT. THE DEVICE WAS RETURNED FOR EVALUATION. THE UNIT WAS INSPECTED FOCUSING ON THE LUER HUB AREA OBSERVING A SPLINTERED CONDITION AND A CRACKED LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158497 ↗
• InjuryJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING THE OPERATION, AN ABNORMALITY WAS FOUND DURING THE USE OF THE CONTRAST 5F TEMPO VER CATHETER. THE CATHETER WAS REMOVED AND FOUND TO BE FRACTURED WHILE INSIDE THE BODY. THE CATHETER WAS REMOVED UNDER ULTRASOUND AND MEASURED TO BE ABOUT 12 CM.THE SURGERY PERFORMED WAS A LEFT PERCUTANEOUS ENDO-VENOUS LASER TREATMENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468457 ↗
• MalfunctionFeb 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, PER ANVISA NOTIFICATION (B)(4), THE PRESENCE OF A FOREIGN BODY WAS OBSERVED INSIDE THE PACKAGING OF A 5F 100 CM TEMPO VERTEBRAL (VERT) CATHETER. THERE WAS NO REPORTED PATIENT INJURY. CUSTOMER IDENTIFICATION WAS NOT PROVIDED IN THE ANVISA WEBSITE, AND THE SUBMITTER DID NOT HAVE MORE INFORMATION ABOUT THIS CASE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, COULD NOT BE OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772210 ↗
• InjuryDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A TEMPO 5 VERTEBRAL (VERT) GUIDEWIRE BROKE, AS THE CATHETER WAS EXTERNALLY WITHDRAWN FOR LEFT INTERNAL CAROTID ANGIOGRAPHY AND TWO THIRDS OF THE CATHETER REMAINED IN THE AORTA. AN UNKNOWN 10F VASCULAR SHEATH WAS INSERTED IN THE RIGHT INGUINAL REGION, AND AN UNKNOWN 6F VASCULAR SHEATH WAS INSERTED UNDER LOCAL ANESTHESIA IN THE LEFT GROIN BY PUNCTURING THE LEFT AORTA. THE USE OF AN UNKNOWN STIFF GUIDEWIRE, A PIGTAIL CATHETER, AND A NON-CORDIS CATHETER WAS INEFFECTIVE IN PULLING DOWN THE CATHETER. THE DISTAL END OF THE CATHETER WAS CAPTURED BY INTRODUCING A RECOVERY CATHETER AND A GOOSENECK CATCHER THROUGH THE RIGHT VASCULAR SHEATH AND PULLED INTO THE RECOVERY CATHETER. AFTER SUCCESSFUL CAPTURE, THE CATHETER AND CATCHER WERE WITHDRAWN AND VASCULARIZED. IF THE CATHETER HAD NOT BEEN REMOVED IN TIME, THE PATIENT MIGHT HAVE NEEDED TO BE TRANSFERRED TO THE HOSPITAL FOR SURGICAL REMOVAL, WHICH WOULD HAVE PROLONGED THE PATIENT'S RECOVERY TIME AND RAISE THE RISK OF COMPLICATIONS SUCH AS ARTERIAL DISSECTION. THE PATIENT HAD UNDERGONE CEREBRAL ANGIOGRAPHY IN THE CATHETERIZATION LABORATORY DUE TO CEREBRAL STENOSIS. THE PATIENT HAD SIGNIFICANT VASCULAR TORTUOSITY AND SEVERE STENOSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245560 ↗
• InjuryJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 135-DEGREE 100 CM VERTEBRAL TEMPO CATHETER BROKE IN THE BLOOD VESSEL AND WAS REMOVED AFTER CAPTURE. A NEW ANGIOGRAPHY CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. THE FEMORAL ARTERY WAS PUNCTURED, THE CATHETER WAS ADVANCED ALONG THE UNKNOWN GUIDEWIRE. THE CONTRAST CATHETER WAS BROKEN DURING 1.5 TURNS OF TORSION-CONTROLLED ROTATION ALONG THE GUIDEWIRE IN THE VESSEL. AFTER THE DEVICE FRACTURED, A CAPTURE DEVICE WAS USED TO GRASP OUT AND REPLACE THE CONTRAST TUBE FOR IMAGING. THE TARGET SITE VESSEL WAS MILDLY CALCIFIED, MILDLY TORTUOUS AND THERE WAS 80% STENOSIS. HOWEVER, THERE WAS NO BIFURCATION OR ACUTE ANGULATION OF THE TARGET SITE VESSEL. THERE WAS NO CALCIFICATION, TORTUOSITY, ACUTE ANGULATION, OR BIFURCATION OF THE ACCESS SITE VESSEL. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WAS NOT TORQUED OR ¿STEERED¿ BY THE HUB. THERE WERE NO DIFFICULTIES INSERTING OR ADVANCING THE CATHETER. THE CATHETER WAS INSERTED ALONG THE GUIDEWIRE DURING THE TWIST CONTROL. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE MALE PATIENT WEIGHED 75KG AND WAS UNDERGOING NEUROSURGERY FOR WHOLE BRAIN IMAGING. THIS WAS A ROUTINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069467 ↗
• MalfunctionApr 6, 2023Leak/Splash; Leak/Splash

  AS REPORTED, WHEN FLUSHING A 5F 100CM 135-DEGREE ANGLED TEMPO DIAGNOSTIC CATHETER WITH SALINE, THE PROXIMAL END OF THE WHITE WAS FOUND LEAKING AND THE DEVICE COULD NOT BE USED. AS A RESULT, AN UNKNOWN CATHETER WAS USED AS A REPLACEMENT. THE UNKNOWN CATHETER WAS ABLE TO BE FLUSHED WITHOUT EVIDENCE OF LEAKAGE. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE DEVICE WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688566 ↗