TEMPO 451531H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705032008587), received between Mar 15, 2019 and Nov 10, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Crack” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, THE BODY OF 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513310 ↗
• 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 23509281 ↗
• MalfunctionNov 18, 2024Crack; Degraded; Crack; Degraded

  AS REPORTED, THE FOUR 5F TEMPO SIM2 CONTRAST CATHETERS HAD CRACKS. THE CRACKS WERE LOCATED ON THE BODY OF THE CATHETER, WHICH WERE NOTICED DURING PREPARATION. THE ISSUE WAS DISCOVERED WHEN OPENING THE PACKAGING. THE CATHETERS WERE FOUND TO HAVE DEGRADATION. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER TEMPO DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS STORED HANGING IN THE DISPOSABLE'S CABINET. THE DEVICE WAS PREPPED PER THE IFU, BUT IT WAS NOT USED. THE ACCESS SITE WAS FEMORAL, AND THE INTENDED PROCEDURE TARGETED CAROTID ARTERY STENOSIS. THE LESION WAS LITTLE CALCIFIED, WITH NO VESSEL TORTUOSITY NOTED. THESE DEVICES WERE NO EXPOSED TO ANY UV LIGHT DURING THE PROCEDURE. THESE DEVICES WERE NO EXPOSED TO HIGH TEMPERATURES. IT IS UNKNOWN IF THE DEVICES CAME FROM THE SAME BOX. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704351 ↗
• MalfunctionNov 18, 2024Crack; Degraded; Crack; Degraded

  AS REPORTED, THE FOUR 5F TEMPO SIM2 CONTRAST CATHETERS HAD CRACKS. THE CRACKS WERE LOCATED ON THE BODY OF THE CATHETER, WHICH WERE NOTICED DURING PREPARATION. THE ISSUE WAS DISCOVERED WHEN OPENING THE PACKAGING. THE CATHETERS WERE FOUND TO HAVE DEGRADATION. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER TEMPO DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS STORED HANGING IN THE DISPOSABLE'S CABINET. THE DEVICE WAS PREPPED PER THE IFU, BUT IT WAS NOT USED. THE ACCESS SITE WAS FEMORAL, AND THE INTENDED PROCEDURE TARGETED CAROTID ARTERY STENOSIS. THE LESION WAS LITTLE CALCIFIED, WITH NO VESSEL TORTUOSITY NOTED. THESE DEVICES WERE NO EXPOSED TO ANY UV LIGHT DURING THE PROCEDURE. THESE DEVICES WERE NO EXPOSED TO HIGH TEMPERATURES. IT IS UNKNOWN IF THE DEVICES CAME FROM THE SAME BOX. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704309 ↗
• MalfunctionNov 18, 2024Crack; Degraded; Crack; Degraded

  AS REPORTED, THE FOUR 5F TEMPO SIM2 CONTRAST CATHETERS HAD CRACKS. THE CRACKS WERE LOCATED ON THE BODY OF THE CATHETER, WHICH WERE NOTICED DURING PREPARATION. THE ISSUE WAS DISCOVERED WHEN OPENING THE PACKAGING. THE CATHETERS WERE FOUND TO HAVE DEGRADATION. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER TEMPO DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS STORED HANGING IN THE DISPOSABLE'S CABINET. THE DEVICE WAS PREPPED PER THE IFU, BUT IT WAS NOT USED. THE ACCESS SITE WAS FEMORAL, AND THE INTENDED PROCEDURE TARGETED CAROTID ARTERY STENOSIS. THE LESION WAS LITTLE CALCIFIED, WITH NO VESSEL TORTUOSITY NOTED. THESE DEVICES WERE NO EXPOSED TO ANY UV LIGHT DURING THE PROCEDURE. THESE DEVICES WERE NO EXPOSED TO HIGH TEMPERATURES. IT IS UNKNOWN IF THE DEVICES CAME FROM THE SAME BOX. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704257 ↗
• MalfunctionNov 18, 2024Crack; Degraded; Crack; Degraded

  AS REPORTED, THE FOUR 5F TEMPO SIM2 CONTRAST CATHETERS HAD CRACKS. THE CRACKS WERE LOCATED ON THE BODY OF THE CATHETER, WHICH WERE NOTICED DURING PREPARATION. THE ISSUE WAS DISCOVERED WHEN OPENING THE PACKAGING. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER TEMPO DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS STORED HANGING IN THE DISPOSABLE'S CABINET. THE DEVICE WAS PREPPED PER THE IFU, BUT IT WAS NOT USED. THE ACCESS SITE WAS FEMORAL, AND THE INTENDED PROCEDURE TARGETED CAROTID ARTERY STENOSIS. THE LESION WAS LITTLE CALCIFIED, WITH NO VESSEL TORTUOSITY NOTED. THESE DEVICES WERE NO EXPOSED TO ANY UV LIGHT DURING THE PROCEDURE. THESE DEVICES WERE NO EXPOSED TO HIGH TEMPERATURES. IT IS UNKNOWN IF THE DEVICES CAME FROM THE SAME BOX. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704214 ↗
• MalfunctionNov 5, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  AS REPORTED, CRACKS WERE NOTED ON THE 5F 100 CM SIDEWINDER II (SIM 2) TEMPO CONTRAST CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER TEMPO CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS FOR CAROTID ARTERY STENOSIS. THE TERM ¿CRACKED¿ REFERS TO THE POLYMER MATERIAL OF THE DEVICE BREAKING BUT NOT INTO TWO OR MORE PIECES. THE DAMAGE, WHICH INCLUDED MANY CRACKS ON THE SURFACE OF THE ANGIOGRAPHIC TUBE, WAS NOTICED WHEN THE PACKAGE WAS OPENED, SPECIFICALLY ON THE BODY SHAFT. A PICTURE OF THE DAMAGED DEVICE WAS PROVIDED. THE ISSUE WAS NOTICED DURING PREPARATION. THE TARGET LESION WAS CAROTID ARTERY STENOSIS WITH SEVENTY PERCENT (70%) STENOSIS, NO CALCIFICATION, AND NO TORTUOSITY. ANOMALIES WERE NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT USED, SO NO DIFFICULTIES, RESISTANCE, OR UNUSUAL FORCE WERE EXPERIENCED DURING THE PROCEDURE. THE TIP WAS NOT VISIBLE ON FLUOROSCOPY AS THE DEVICE WAS NOT USED. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608854 ↗
• InjuryOct 7, 2024Crack; Degraded; Detachment of Device or Device Component; Crack; Degraded; Detachment of Device or Device Component

  AS REPORTED, 5F TEMPO SIM2 ANGIOGRAPHIC CATHETER WAS USED DURING INTERVENTIONAL RADIOLOGY (IR) PROCEDURE. THE TIP OF CATHETER SNAPPED OFF THE MAIN BODY OF CATHETER LEAVING APPROXIMATELY 6CM OF CATHETER IN PATIENT. THE FRAGMENTED CATHETER TIP WAS SNARED AND REMOVED BY THE PHYSICIAN. THERE WAS NO ADVERSE EVENT REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S CATHETER. THE DEVICE WILL BE RETURNED FOR EVALUATION. FEMORAL ACCESS WAS USED. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE NOTICED PRIOR TO USE. IT IS UNKNOWN WHETHER THE BREAK HAPPENED DURING ADVANCING THROUGH THE VESSEL OR WHILE REMOVING/WITHDRAWING. NO UNUSUAL FORCE WAS NEEDED TO ADVANCE OR WITHDRAW THE CATHETER FROM THE PATIENT. THE INTENDED PROCEDURE WAS SIRT WORKUP CANNULATION OF THE CELIAC TRUNK, WITH VESSEL AND LESION CHARACTERISTICS PRESENTING NO CONCERNS. THE LESION WAS NOTED TO HAVE LITTLE CALCIFICATION AND LITTLE VESSEL TORTUOSITY. A NON-CORDIS 0.035 GLIDEWIRE WAS USED. THERE WAS NO RESISTANCE WHEN ADVANCING OVER THE GLIDEWIRE. ALL CATHETERS WITH SAME LOT NUMBER REMOVED FROM SHELVES BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384947 ↗
• InjuryJun 3, 2024Difficult to Remove; Difficult to Remove

  AS REPORTED, POST IMAGING FOR A TOTAL CEREBRAL ANGIOGRAM, THE 5F 100CM SIDEWINDER (SIM) 2 TEMPO DIAGNOSTIC CATHETER WAS WITHDRAWN TO THE BRACHIAL ARTERY AND THE CONTRAST CATHETER KINKED. MULTIPLE ATTEMPTS THAT WERE MADE TO UNTWIST IT WERE UNSUCCESSFUL, WITH THE CATHETER HEAD ROTATING TOGETHER EACH TIME. THERE WAS A PATIENT INJURY AND THE PATIENT WAS TREATED WITH ANALGESIC AND ANTISPASMODIC TREATMENT. THE OPERATOR ATTEMPTED EXTRACORPOREAL PRESSURE ON THE TIP OF THE CATHETER TO UNTWIST IT, WHICH WAS STILL UNSUCCESSFUL. THE PHYSICIAN WAS ASKED TO CONSULT. AFTER C-ARM LOCALIZATION, THE SKIN WAS INCISED AT THE CATHETER BEND AND THE VESSEL WAS BLUNTLY ISOLATED. THE OPERATOR PINCHED THE CATHETER OUTSIDE THE VESSEL DISTAL TO THE CATHETER BEND, ROTATED THE CATHETER COUNTERCLOCKWISE TO UNTWIST IT, AND THEN WITHDREW THE CATHETER THROUGH THE CATHETER SHEATH. THERE WERE DIFFICULTIES ENCOUNTERED WHILE ATTEMPTING TO WITHDRAW THE DEVICE. AFTERWARDS, THE SKIN TEMPERATURE, COLOR AND DISTAL VASCULAR PULSATION OF THE RIGHT UPPER EXTREMITY WERE CLOSELY OBSERVED, AND SYMPTOMATIC TREATMENTS SUCH AS PAIN RELIEF AND DRESSING CHANGE AT THE INCISION WERE GIVEN. THE FOLLOWING DAY, THE MUSCLE STRENGTH OF THE R

  Patient problems: Vasoconstriction

  MAUDE report 19450164 ↗
• MalfunctionDec 1, 2023Crack; Crack

  AS REPORTED, THE TIP END OF A 5F TEMPO SIDEWINDER II (SIM2) DIAGNOSTIC ANGIOGRAPHY CATHETER FRACTURED DURING THE PROCEDURE AFTER ENTERING THE BODY AND WAS REMOVED FROM THE PATIENT. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245705 ↗
• MalfunctionNov 3, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, A HOLE WAS FOUND IN THE OUTER PACKAGING OF A 100CM TEMPO SIDEWINDER II (SID) ANGIOGRAPHIC CATHETER, WHICH DISRUPTED THE STERILE CONDITION AND PREVENTED THE USE OF THE CATHETER. A NEW ANGIOGRAPHY CATHETER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. THE CONDITION OF THE ORIGINAL PACKAGE WAS NOTED DURING PREP, WHEN UNPACKING THE PRODUCT. THE WHOLE BOX WAS KEPT IN THE ¿CONSUMABLE¿ CABINET IN THE OPERATING ROOM. THE PRODUCT WAS NOT DAMAGED, BUT THE STERILE ENVIRONMENT WAS BROKEN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066357 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE MANIPULATING THE ANGLE OF A 5F 100CM SIDEWINDER 2 TEMPO DIAGNOSTIC CATHETER, THE CATHETER FRACTURED AT ABOUT 40CM FROM THE PROXIMAL END OF THE CATHETER. THIS OCCURRED AS A RESULT OF ROTATING THE CATHETER SEVERAL TIMES OUTSIDE THE BODY. A "CATCHER" WAS USED TO GRAB THE BROKEN CONTRAST TUBE OUT OF THE BODY. THE PATIENT WAS NOT HARMED FROM THIS CONTRAST CATHETER. THE OPERATION ENDED MIDWAY, AND NO OTHER TREATMENT WAS GIVEN TO THE PATIENT. INTERVENTIONAL SURGEONS HAD BEEN ATTEMPTING TO PERFORM LEFT SUBCLAVIAN ARTERY ANGIOGRAPHY ON THE PATIENT, AND THE DIAGNOSTIC CATHETER HAD BEEN DELIVERED TO THE LEFT SUBCLAVIAN ARTERY FROM THE FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS USED. THE TARGET SITE WAS MILDLY CALCIFIED AND SEVERELY TORTUOUS. IT ALSO HAD ACUTE ANGULATION AND BIFURCATION IN THE VESSEL. THERE WAS 90% STENOSIS OF THE TARGET SITE. ON THE OTHER HAND, 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. THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. THE USER WAS TRAINED IN THE USE OF THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056756 ↗
• MalfunctionJun 3, 2019Crack; Crack

  DURING A PERIPHERAL ARTERY CATHETERIZATION, THE PHYSICIAN REQUESTED A TEMPO CATHETER 5F SIM 2 100CM, AFTER SHORT MANIPULATION THE PHYSICIAN REMOVED THE CATHETER AND THEN NOTICED A FRACTURE IN THE DISTAL END. PER FAL ANALYSIS, THE BODY SHAFT OF THE DEVICE WAS FOUND CRACKED AT 4.5 CM AND AT 10.5 CM FROM THE TIP. THE CATHETER WAS REMOVED SAFELY, AND NO PART REMAINED IN THE PATIENT BODY. THEN, AFTER REMOVING THE CATHETER HE OPENED A SECOND TEMPO CATHETER FROM THE SAME LOT AND BEFORE INSERTING IT INTO THE INTRODUCER, WHILE PREPARING THE CATHETER THE PHYSICIAN NOTICED THE CATHETER KINKED. PER FAL ANALYSIS, THE BODY SHAFT OF THE DEVICE WAS FOUND CRACKED AT 7.5 CM FROM THE TIP. THERE WERE NO REPORTED PATIENT INJURIES. THE FIRST CATHETER USED WAS PROPERLY PREPARED AND INSERTED OVER THE WIRE INTO THE SHEATH. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED A CORDIS SIM 1 CATHETER WITH NO FURTHER PROBLEM. THE DEVICES WERE STORED IN THEIR ORIGINAL PACKAGING ON THE SHELF IN THE CATH LAB. THE DEVICES WERE STORED FOR MORE THAN A YEAR. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE IFU. THERE WERE NO DIFFICULTIES EXPERIENCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662708 ↗
• MalfunctionMar 18, 2019Crack; Crack

  DURING A PERIPHERAL ARTERY CATHETERIZATION, THE PHYSICIAN REQUESTED A TEMPO CATHETER 5F SIM 2 100CM, AFTER SHORT MANIPULATION THE PHYSICIAN REMOVED THE CATHETER AND THEN NOTICED A FRACTURE IN THE DISTAL END. THE CATHETER WAS REMOVED SAFELY, AND NO PART REMAINED IN THE PATIENT BODY. THEN, AFTER REMOVING THE CATHETER, HE OPENED A SECOND TEMPO CATHETER FROM THE SAME LOT AND BEFORE INSERTING IT INTO THE INTRODUCER, WHILE PREPARING THE CATHETER, THE PHYSICIAN NOTICED THE CATHETER KINKED. THERE WERE NO REPORTED PATIENT INJURIES. THE FIRST CATHETER USED WAS PROPERLY PREPARED AND INSERTED OVER THE WIRE INTO THE SHEATH. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED A CORDIS SIM 1 CATHETER WITH NO FURTHER PROBLEM. THE DEVICES WERE STORED IN THEIR ORIGINAL PACKAGING ON THE SHELF IN THE CATH LAB. THE DEVICES WERE STORED FOR MORE THAN A YEAR. THE DEVICES WERE STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE IFU. THERE WERE NO DIFFICULTIES EXPERIENCED IN PREPPING THE DEVICES. THERE WERE NO ANOMALIES NOTED TO THE DEVICES WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCTS FROM THE PACKAGING. THE CATHETER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429683 ↗
• InjuryMar 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, THE BODY/SHAFT OF THE TEMPO SIM 2 100 CM CATHETER DIAGNOSTIC SEPARATED. THERE WAS NO PATIENT INJURY. ALL OF THE DEVICE WERE REMOVED WITH SURGICAL INSTRUMENTS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE RIGHT FEMORAL ARTERY WAS PUNCTURED AND CATHETERIZED IN ORDER TO COMPLETE DIAGNOSTIC PROCEDURE. THE TEMPO DIAGNOSTIC CATHETER SIM 2 WAS INTRODUCED USING AN UNKNOWN 0,035¿ 300 GUIDING CATHETER. DURING CATHETERIZATION, COMPLETE TRANSVERSE SEPARATION OF THE TEMPO CATHETER WAS DISCOVERED. ALL THE INSTRUMENTS HAD TO BE EXTRACTED AND THE PHYSICIAN MADE A DECISION TO CONTINUE OPERATION VIA RIGHT FEMORAL ARTERY. THERE WAS NO EXCESSIVE FORCE USED DURING THE PROCEDURE. THE OPERATION WAS COMPLETED SUCCESSFULLY, BUT TOOK TWO MORE HOURS THAN EXPECTED. ANOTHER LOCAL ANESTHESIA HAD TO BE PERFORMED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425096 ↗