GLIDEWIRE GR3508Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04987350773197), received between Oct 18, 2016 and Oct 28, 2025 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Break; Break

  TERUMO MEDICAL RECEIVED TWO FDA MEDWATCH REPORTS # MW5175308. THE EVENT DESCRIPTION STATES: "GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON JULY 11. WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME, WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 23408968 ↗
• InjuryOct 28, 2025Break; Break

  TERUMO MEDICAL RECEIVED TWO FDA MEDWATCH REPORTS # MW5175308. THE EVENT DESCRIPTION STATES: "GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON JULY 11. WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME, WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 23408950 ↗
• InjuryJul 1, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE WAS SEVERED DURING A NEURO PROCEDURE INSIDE THE PATIENT'S INTERNAL JUGULAR VEIN. THE SEVERED PARTS OF THE WIRE WERE SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVELY AND DID NOT RESULT IN PATIENT INJURY OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 03 JUN 2025: TWO SEVERED PIECES WERE SNARED. THE PATIENT IS STABLE. A NAVICROSS, ANGLED, WAS USED WITH THE GLIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22375291 ↗
• InjuryJul 1, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE WAS SEVERED DURING A NEURO PROCEDURE INSIDE THE PATIENT'S INTERNAL JUGULAR VEIN. THE SEVERED PARTS OF THE WIRE WERE SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVELY AND DID NOT RESULT IN PATIENT INJURY OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 03 JUN 2025: TWO SEVERED PIECES WERE SNARED. THE PATIENT IS STABLE. A NAVICROSS, ANGLED, WAS USED WITH THE GLIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22375290 ↗
• InjurySep 6, 2024Unraveled Material; Unraveled Material

  TERUMO MEDICAL OBTAINED AN FDA MEDWATCH REPORT # MW5157027. THE EVENT DESCRIPTION STATES: THAT A TIPS PROCEDURE WAS CARRIED OUT, DURING WHICH A 180CM ANGLED GLIDEWIRE WITH A HYDROPHILIC COATING WAS UTILIZED. DURING THE PROCESS, PART OF THE COATING DETACHED FROM THE WIRE WITHIN THE LIVER. THE STRIPPED COATING IS VISIBLE UNDER FLUOROSCOPY AND, BEING IRRETRIEVABLE, REMAINS IN THE LIVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20158765 ↗
• InjurySep 6, 2024Unraveled Material; Unraveled Material

  TERUMO MEDICAL OBTAINED AN FDA MEDWATCH REPORT # MW5157027. THE EVENT DESCRIPTION STATES: THAT A TIPS PROCEDURE WAS CARRIED OUT, DURING WHICH A 180CM ANGLED GLIDEWIRE WITH A HYDROPHILIC COATING WAS UTILIZED. DURING THE PROCESS, PART OF THE COATING DETACHED FROM THE WIRE WITHIN THE LIVER. THE STRIPPED COATING IS VISIBLE UNDER FLUOROSCOPY AND, BEING IRRETRIEVABLE, REMAINS IN THE LIVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20158764 ↗
• InjuryNov 28, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE CASE WAS A RIGHT FEMORAL ARTERIAL ACCESS WITH A MICRO PUNCTURE KIT AND EXCHANGE FOR FIVE FRENCH MERIT VERTEBRAL CATHETER OVER BENTSEN WIRE. THE SUBJECT WIRE .035, 180 CM ANGLE GLIDE WIRE WAS INSERTED THROUGH A THREE-WAY STOPCOCK TO ADVANCE THE CATHETER TO THE TARGET SITE BEYOND THE RIGHT CAROTID ARTERY. THE GLIDEWIRE WAS REMOVED SMOOTHLY WITHOUT INCIDENT. A RIGHT CEREBRAL ANGIOGRAM WAS OBTAINED. AN X-RAY ARTIFACT FOUND NEAR THE AREA WHERE THE GLIDEWIRE WAS PREVIOUSLY. THE PATIENT'S HAIR AND X-RAY TABLE WERE INSPECTED IN AN ATTEMPT TO LOCATE THE EXTERNAL X-RAY ARTIFACT; HOWEVER, NONE WAS FOUND. AN ABNORMALITY WAS NOTED ON THE LEADING EDGE OF GLIDE WIRE BY A TECH. THE TECH NOTED IT LOOKED LIKE A FIBER ON THE LEADING EDGE. IT WAS SUSPECTED THAT THE TIP OF THE GLIDE WIRE BECAME SEPARATED FROM THE WATER BODY AND WAS INSIDE THE PATIENT. ADDITIONALLY, A RIGHT CEREBRAL ANGIOGRAM WAS OBTAINED. A SNAER CATHETER SYSTEM WAS INSERTED IN AN ATTEMPT TO REMOVE THE X-RAY ARTIFACT; HOWEVER, IT WAS UNSUCCESSFUL AS THE ARTIFACT BECAME DISLODGED AND TRAVELED INTO THE DISTAL CEREBRAL ARTERY. THE X-RAY ARTIFACT WAS LEFT IN THE PATIENT. THE CATHETER AND SHEATH WERE REMO

  Patient problems: Foreign Body In Patient

  MAUDE report 18221540 ↗
• MalfunctionOct 16, 2023

  TIP OF GUIDEWIRE FRACTURED AND BROKE OFF DURING THE PROCEDURE. TIP MIGRATED, UNABLE TO RETRIEVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17949573 ↗
• MalfunctionMar 21, 2023Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD A FEMORAL ANGIOGRAM PROCEDURE. A VS2 CATHETER WAS ADVANCED UP-AND-OVER THE AORTIC BIFURCATION. THE GLIDEWIRE ADVANCED THROUGH THE CATHETER INTO THE CALCIFIED STENOSIS IN PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE CATHETER ADVANCED JUST PROXIMAL TO CALCIFICATION AND THE GLIDEWIRE WAS NOT ABLE TO ADVANCE FURTHER. THE PHYSICIAN ATTEMPTED TO TORQUE THE GLIDEWIRE AND WITHDRAW AS THE WIRE APPEARED TO BE STUCK IN CALCIFICATION. AT SOME POINT THE PHYSICIAN NOTED THAT WIRE WAS PULLING BACK BUT THAT TIP OF WIRE APPEARED TO BE HANGING OUT OF TIP OF CATHETER. SCRUB TECH USED SYRINGE TO PULL NEGATIVE PRESSURE ON CATHETER WHILE PHYSICIAN WITHDREW CATHETER UNDER IMAGING. THE TIP OF THE WIRE TRAVELLED THROUGH THE CATHETER AND INTO THE SYRINGE. A NEW WIRE WAS OPENED AND THE PROCEDURE CONTINUED. THE PATIENT WAS STABLE AND DISCHARGED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585763 ↗
• MalfunctionMar 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THE GUIDEWIRE INVOLVED WAS USED IN THE ATTEMPT TO RETRIEVE AN INFERIOR VENA CAVA (IVC) FILTER. THE WIRE FLAWED WHEN IT WAS BEING REMOVED FROM THE CATHETER. THE PATIENT HAD NO ISSUES. THE OUTCOME OF THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 24 FEB 2022: THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO COMPLICATIONS WITH THE PROCEDURE BEING COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695526 ↗
• InjuryJul 21, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR USED THE GLIDEWIRE THROUGH A NEEDLE INTO THE PERICARDIUM AND IT APPEARED THAT PART OF IT BECAME SHEARED OFF. THE PIECE WAS LEFT IN THE PATIENT AND THEN APPEARS TO BE NO ISSUES WITH THE PATIENT DUE TO THIS OCCURRENCE. IT WAS NOT REMOVED. TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "PT WAS ON THE TABLE HAVING A PERICARDIOCENTESIS AND PHYSICIAN USING A TERUMO GUIDE WIRE AND WHEN THE WIRE WAS BEING REMOVED, THE DISTAL PART OF THE GUIDEWIRE WAS RETAINED IN THE PERICARDIAL SPACE, PHYSICIAN AWARE W/ NO HARM TO THE PATIENT AND IMAGE CAPTURED ON FLUORO IN PT CHART." THE ORIGINAL INTENDED PROCEDURE WAS A PERICARDIOCENTESIS. THE LOCATION WHERE THE EVENT OCCURRED WAS THE ELECTROPHYSIOLOGY LAB.

  Patient problems: Foreign Body In Patient

  MAUDE report 12202984 ↗
• InjuryJul 21, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR USED THE GLIDEWIRE THROUGH A NEEDLE INTO THE PERICARDIUM AND IT APPEARED THAT PART OF IT BECAME SHEARED OFF. THE PIECE WAS LEFT IN THE PATIENT AND THEN APPEARS TO BE NO ISSUES WITH THE PATIENT DUE TO THIS OCCURRENCE. IT WAS NOT REMOVED. TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "PT WAS ON THE TABLE HAVING A PERICARDIOCENTESIS AND PHYSICIAN USING A TERUMO GUIDE WIRE AND WHEN THE WIRE WAS BEING REMOVED, THE DISTAL PART OF THE GUIDEWIRE WAS RETAINED IN THE PERICARDIA! SPACE, PHYSICIAN AWARE W/ NO HARM TO THE PATIENT AND IMAGE CAPTURED ON FLOURO IN PT CHART." THE ORIGINAL INTENDED PROCEDURE WAS A PERICARDIOCENTESIS. THE LOCATION WHERE THE EVENT OCCURRED WAS THE ELECTROPHYSIOLOGY LAB.

  Patient problems: Foreign Body In Patient

  MAUDE report 12202978 ↗
• MalfunctionJul 13, 2021Output Problem

  PT WAS ON THE TABLE HAVING A PERICARDIOCENTESIS AND PHYSICIAN USING A TERUMO GUIDE WIRE AND WHEN THE WIRE WAS BEING REMOVED, THE DISTAL PART OF THE GUIDEWIRE WAS RETAINED IN THE PERICARDIAL SPACE, PHYSICIAN AWARE W/ NO HARM TO THE PATIENT AND IMAGE CAPTURED ON FLOURO IN PT CHART.

  Patient problems: Foreign Body In Patient

  MAUDE report 12158297 ↗
• InjuryFeb 28, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE SHEARED OFF IN A TIPS PROCEDURE. THE GLIDEWIRE TIP WAS LEFT IN PATIENT OVERNIGHT AND REMOVED WITH SNARE THE NEXT DAY. THE BLOOD LOSS WAS LESS THAN 250 CC'S. THE PATIENT REQUIRED REMOVAL OF GLIDEWIRE TIP THROUGH ENDOVASCULAR PROCEDURE. THE TIPS PROCEDURE WAS A SUCCESS; HOWEVER, THE PATIENT PASSED AWAY THE FOLLOWING DAY FROM BLEEDING GASTRIC VARICES. ADDITIONAL INFORMATION RECEIVED ON 06FEB2020. THE DOCTOR DID NOT FEEL THAT THE SHEARED OFF GLIDEWIRE TIP LED OR CAUSED THE DEATH OF THE PATIENT; THE PATIENT HAD SEVERE LIVER FAILURE AND PASSED DUE TO LIVER INSUFFICIENCY AND CHOLANGITIS. THE TIP OF THE GLIDEWIRE SEPARATED IN THE PULMONARY ARTERY. THE SHEARED TIP DID NOT CAUSE A RUPTURE IN THE VESSEL IT WAS EMBEDDED IN; 1 CM WIRE CORE AND 1 CM OUTER COVERING WERE SUCCESSFULLY REMOVED WITH A SNARE. AFTER THE TIP WAS SNARED AND REMOVED THE NEXT DAY, THE PATIENT WAS IN STABLE CONDITION, AND THE TIPS PROCEDURE WAS PERFORMED AFTERWARDS. THE TIPS PROCEDURE WAS NOT SUCCESSFUL; LIVER WAS SEVERELY CIRRHOTIC AND PORTAL VEIN WAS TINY. OTHER CO-MORBIDITIES THE PATIENT HAD WAS HEPATIC INSUFFICIENCY (MELD SCORE 20) AND WAS ADMITTED TO THE HOSPITAL WITH SEVER

  Patient problems: Blood Loss

  MAUDE report 9770438 ↗
• InjuryFeb 28, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE SHEARED OFF IN A TIPS PROCEDURE. THE GLIDEWIRE TIP WAS LEFT IN PATIENT OVERNIGHT AND REMOVED WITH SNARE THE NEXT DAY. THE BLOOD LOSS WAS LESS THAN 250 CC'S. THE PATIENT REQUIRED REMOVAL OF GLIDEWIRE TIP THROUGH ENDOVASCULAR PROCEDURE. THE TIPS PROCEDURE WAS A SUCCESS; HOWEVER, THE PATIENT PASSED AWAY THE FOLLOWING DAY FROM BLEEDING GASTRIC VARICES. ADDITIONAL INFORMATION RECEIVED ON 06FEB2020. THE DOCTOR DID NOT FEEL THAT THE SHEARED OFF GLIDEWIRE TIP LED OR CAUSED THE DEATH OF THE PATIENT; THE PATIENT HAD SEVERE LIVER FAILURE AND PASSED DUE TO LIVER INSUFFICIENCY AND CHOLANGITIS. THE TIP OF THE GLIDEWIRE SEPARATED IN THE PULMONARY ARTERY. THE SHEARED TIP DID NOT CAUSE A RUPTURE IN THE VESSEL IT WAS EMBEDDED IN; 1CM WIRE CORE AND 1CM OUTER COVERING WERE SUCCESSFULLY REMOVED WITH A SNARE. AFTER THE TIP WAS SNARED AND REMOVED THE NEXT DAY, THE PATIENT WAS IN STABLE CONDITION, AND THE TIPS PROCEDURE WAS PERFORMED AFTERWARDS. THE TIPS PROCEDURE WAS NOT SUCCESSFUL; LIVER WAS SEVERELY CIRRHOTIC AND PORTAL VEIN WAS TINY. OTHER CO-MORBIDITIES THE PATIENT HAD WAS HEPATIC INSUFFICIENCY (MELD SCORE 20) AND WAS ADMITTED TO THE HOSPITAL WITH SEVERE

  Patient problems: Blood Loss

  MAUDE report 9770437 ↗
• InjuryApr 26, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE WAS USED DURING A PERIPHERAL CASE. THE DOCTOR HAD ACCESS IN BOTH GROINS. HE USED THE ANGLED GLIDEWIRE TO GET UP AND OVER THE ILIACS. THE GLIDEWIRE WAS PLACED IN THE LEFT GROIN ACCESS AND SNARED INTO THE RIGHT. THE DOCTOR BELIEVES THAT THE WIRE WAS WEAKENED WHERE IT WAS GRIPPED AND PULLED BY THE STARE. FLUOROSCOPY REVEALED THAT PART OF THE WIRE WAS LEFT IN THE LEFT ILIAC. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE BROKEN PART OF THE WIRE. THE PATIENT WAS FINE AND IN STABLE CONDITION. THE CASE WAS SUCCESSFULLY COMPLETED. THE BLOOD LOSS WAS LESS THAN 250 CC. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 12, 2019. IT APPEARED TO BE ACTUAL WIRE BREAKAGE, AND APPROXIMATELY 1/2 THE ORIGINAL LENGTH.

  Patient problems: No Code Available

  MAUDE report 8555889 ↗
• InjuryJul 30, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED A GLIDEWIRE WAS INVOLVED IN A CASE THAT TRIGGERED AN INVESTIGATION BY THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH. AN RN (NOT INVOLVED IN THE CASE) MADE A STATEMENT THAT THE PRODUCT SPECIFICALLY WAS NOT AT FAULT AS DEFECTIVE, BUT WAS INVOLVED IN A POTENTIAL MISUSE. THE PATIENT WAS IN STABLE CONDITION, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 13, 2018. THE STATEMENT "INVOLVED IN A POTENTIAL MISUSE" WAS REPORTED TO MEAN THAT THE USER WENT AGAINST IFU. THE PROCEDURES BEING PERFORMED WERE RIGHT CYSTOSCOPY, URETHRAL CATHETER PLACEMENT, RIGHT PYELOGRAM, AND ATTEMPTED RIGHT PERCUTANEOUS NEPHROLITHOTOMY. THE TIP OF THE WIRE WAS RETAINED WITHIN THE LOWER POLE OF THE CALYX AND REMOVAL WAS UNSUCCESSFUL. PER POST-OP REPORT - OPEN ENDED CATHETER. THE C-ARM WAS THEN BROUGHT IN AT THIS TIME AND A SCOUT IMAGE PERFORMED WHICH SHOWED A RIGHT STAGHORN CALCULUS ENCOMPASSING ENTIRETY OF THE RIGHT RENAL COLLECTING SYSTEM. A RETROGRADE PYELOGRAM WAS THEN PERFORMED USING 50 PERCENT DILUTE CONTRAST THROUGH THE OPEN-ENDED CATHETER WHICH SHOWED VERY LITTLE CALYCEAL DILATATION. AS THIS TIME, MULTIPLE ATTEMPTS WERE MADE ASSESSING, AT FIRST

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7731149 ↗
• InjuryJul 5, 2018Material Separation; Material Separation

  THE PATIENT WAS UNDERGOING PORT A CATH PLACEMENT. THE SURGEON INSERTED THE GLIDEWIRE, HOWEVER THE WIRE LOOPED BACK ON ITSELF. THE SURGEON ATTEMPTED TO WITHDRAW THE WIRE, BUT THE PLASTIC COATING SEPARATED FROM THE WIRE AND WAS RETAINED IN THE VESSEL. THE VASCULAR SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT BY NON-INVASIVE MEASURES. SHE WAS FORCED TO COMPLETE AN OPEN RETRIEVAL OF THE GLIDEWIRE FRAGMENTS FROM RIGHT INTERNAL JUGULAR VEIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664329 ↗
• MalfunctionJul 19, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A IVC FILTER REMOVAL ON (B)(6) 2017 AND A 180CM GLIDEWIRE BROKE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. NO KNOWN IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725953 ↗
• InjuryMar 16, 2017Material Fragmentation; Material Fragmentation

  THE USER FACILITY REPORTED COATING ON THE WIRE HAD COME OFF DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DOCTOR PLACING THE GUIDEWIRE FOR PORT PLACEMENT NOTICED THE COATING ON THE WIRE HAD COME OFF WHEN THE PROCEDURE WAS FIRST STARTED; ANOTHER WIRE WAS USED TO COMPLETE THE CASE; BLACK COATING WAS NOTICED ON THE PATIENT'S SKIN; A VASCULAR SURGEON WAS CONSULTED AND ADDITIONAL X-RAYS WERE TAKEN WHERE IT APPEARED A PIECE OF BLACK COATING WAS IN THE VESSEL AND SUB-Q AREA; AND, THE PATIENT WAS REPORTED AS DOING FINE, THIS WAS AN OUTPATIENT PROCEDURE AND THE PATIENT WAS DISCHARGED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6412076 ↗
• InjuryDec 16, 2016Material Separation; Material Separation

  A MEDWATCH REPORT WAS RECEIVED AT TMC ON (B)(6) 2016 THAT STATED THE FOLLOWING: "IN MID-AUGUST THE PATIENT UNDERWENT A LEFT FEMORAL ENDARTERECTOMY, LEFT FEMORAL TO POPLITEAL ARTERY BYPASS ABOVE THE KNEE USING 6 MM POLYTETRAFLUOROETHYLENE (PTFE) GRAFT, OPERATIVE ARTERIOGRAM, AND LEFT ILIAC BALLOON ANGIOPLASTY, WHICH WAS SUCCESSFUL. THE PATIENT DID HAVE SIGNIFICANT BLOOD LOSS DURING THE PROCEDURE REQUIRING BLOOD TRANSFUSIONS POSTOPERATIVELY. WE OBSERVED THERE WAS SOME SMALL AMOUNT OF BLEEDING FROM HIS INCISION WHICH WAS CONTROLLED WITH STAPLES. THE PATIENT STABILIZED AND WAS AMBULATED. BECAUSE OF THE BLOOD LOSS, IT WAS INITIALLY THOUGHT TO MAKE SURE HE DID NOT HAVE ANY RETROPERITONEAL BLEEDING, A CT OF THE ABDOMEN AND PELVIS WAS PERFORMED SHOWING NO EVIDENCE OF BLEEDING; HOWEVER, A WIRE WAS SEEN IN THE LEFT COMMON FEMORAL ARTERY, PROBABLY A PIECE FROM THE WIRE USED AT THE TIME OF HIS BALLOON ANGIOPLASTY OF THE ILIAC ARTERY. INTERVENTIONAL RADIOLOGY WAS CONSULTED AND REMOVED THE OBJECT SUCCESSFULLY WITHOUT COMPLICATION ON THREE DAYS AFTER THE INITIAL SURGERY THROUGH A RIGHT FEMORAL PUNCTURE. PATHOLOGY DESCRIBED THE SPECIMEN AS A GRAY FLEXIBLE THREADLIKE FOREIGN OBJECT MEASURING 10.7 C

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6180637 ↗
• MalfunctionOct 18, 2016Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE COATING HAD COME OFF THE WIRE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE CORE OF WIRE SEPARATED FROM OUTER COATING AT THE DISTAL TIP; THE COATING AND CORE SPLIT BUT DID NOT BREAK FROM THE REMAINING WIRE, THEREFORE NO PIECES WERE LEFT BEHIND IN THE PATIENT; A NEW WIRE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6036140 ↗