PGW .018 SV SHORT 180CM ST
Report
- Report Number
- 1016427-2022-05386
- Event Type
- Injury
- Date Received
- January 5, 2022
- Date of Event
- December 8, 2021
- Report Date
- March 7, 2022
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQX
- UDI-DI
- 10705032056052
- PMA / PMN Number
- K930091
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS CASE IS RELATED TO REPORT NUMBER 1016427-2022-05388. AS REPORTED, A 4.5 F NON -CORDIS SHEATH WAS INSERTED IN THE JUGULAR REGION. TWO NON-CORDIS 014 GUIDEWIRES CROSSED THE LESION. A NON-CORDIS BALLOON CATHETER WAS INSERTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), BUT IT WAS UNABLE TO BE DELIVERED DUE TO SEVERE TORTUOSITY AT THE RIGHT PULMONARY ARTERY (PA). A PGW .018 SV SHORT 180CM ST WIRE WAS USED FOR SUPPORT WITH A NON -CORDIS MICROCATHETER. ONE OF THE WIRES BROKE WHILE ATTEMPTING TO SHAPE IT OUTSIDE OF THE PATIENT. THE DISTAL END OF THE GUIDEWIRE BROKE, AND THE COIL UNRAVELED BY PULLING THE DISTAL END WITH HAND(S). IT WAS REPLACED WITH ANOTHER PGW .018 SV SHORT 180CM ST. THE DISTAL END WAS SHAPED, AND IT CROSSED THE LESION. THE NON -CORDIS BALLOON CATHETER WAS DELIVERED, BUT IT WAS DIFFICULT FOR IT TO CROSS THE TORTUOUS RIGHT PULMONARY ARTERY (PA) AND STENT IMPLANTED REGION. THE PHYSICIAN RETRACTED THE PGW .018 SV SHORT 180CM ST GUIDEWIRE, BUT THE DISTAL END OF THE COIL DID NOT MOVE. THE PHYSICIAN SUSPECTED THE COIL IS UNRAVELED. THE PGW .018 SV SHORT 180CM ST GUIDEWIRE WAS SLOWLY RETRACTED, IT SEPARATED, AND THE COIL STRETCHED. THE SEPARATED PORTION OF THE WIRE REMAINS IN THE PATIENT. THE PHYSICIAN WAS UNABLE TO REMOVE IT. AFTER THE PROCEDURE, THE COIL PART OF THE FIRST PGW .018 SV SHORT 180CM ST GUIDEWIRE WAS SLIGHTLY RETRACTED TO CONFIRM POSSIBILITY OF UNRAVELING THE PGW .018 SV SHORT 180CM ST GUIDEWIRE, BUT IT GOT STRETCHED EASILY. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PEDIATRIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). UNKNOWN STENT(S) WERE IMPLANTED AT THE PA MAIN BLOOD VESSEL AND THE RIGHT PA. THE DISTAL END OF THE RIGHT PA HAD A LESION. THE TARGET SITE WAS THE DISTAL END OF THE RIGHT PULMONARY ARTERY. THE ACCESS SITE WAS IN THE JUGULAR REGION. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. A CONTRALATERAL APPROACH WAS NOT USED, IT WAS MADE FROM THE RIGHT PULMONARY ARTERY. VESSEL CHARACTERISTICS AT TARGET SITE, SHOWED MODERATE TORTUOSITY AND ACUTE ANGLE. THERE WAS 90% STENOSIS NOTED. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. TWO NON-STERILE PGW .018 SV SHORT 180CM ST PERIPHERAL STEERABLE GUIDEWIRE (PGW) UNITS WERE RECEIVED FOR ANALYSIS AND WERE ANALYZED UNDER (B)(4). (B)(4). DURING VISUAL ANALYSIS OF THE PGW .018 SV SHORT 180CM GUIDEWIRE, THE COIL WIRE WAS OBSERVED FRACTURED AND UNRAVELED/STRETCHED DURING VISUAL ANALYSIS. SEM ANALYSIS PRESENTED EVIDENCE OF DUCTILE DIMPLES AND A CUP AND CONE-LIKE SHAPE ON THE FRACTURED WIRE¿S BODY. THE DISTAL PORTION OF THE COIL WIRE WAS OBSERVED FRACTURED/SEPARATED FROM ITSELF. HOWEVER, THE PROXIMAL END OF THE COIL REMAINS ATTACHED TO THE CORE WIRE. (B)(4). DURING VISUAL ANALYSIS OF THE PGW .018 SV SHORT 180CM, THE CORE WIRE WAS OBSERVED FRACTURED/SEPARATED AND THE COIL WIRE WAS UNRAVELED/STRETCHED. SEM ANALYSIS PRESENTED EVIDENCE OF PLASTIC DEFORMATION AND DUCTILE DIMPLES ON THE SEPARATED WIRE¿S BODY. THE DISTAL PORTION OF THE COIL WIRE SEPARATED FROM THE CORE WIRE; HOWEVER, THE PROXIMAL END OF THE COIL REMAINS ATTACHED TO THE CORE WIRE. BOTH DEVICES SHARE THE SAME LOT NUMBER AND A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35262179 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE COMPLAINTS REPORTED BY THE CUSTOMER ¿DISTAL TIP-WIRES-FRACTURED/SEPARATED - IN PATIENT ¿AND ¿DISTAL TIP-WIRES- UNRAVELED/STRETCHED - IN PATIENT ¿WERE CONFIRMED FOR BOTH DEVICES. PLASTIC DEFORMATION, DUCTILE DIMPLES AND A CUP AND CONE-LIKE SHAPE ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE WIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. THE EXACT CAUSE OF THE REPORTED CONDITION CAN NOT BE CONCLUSIVELY DETERMINED DURING THIS ANALYSIS. VESSEL CHARACTERISTICS OR MANIPULATING THE GUIDEWIRE AGAINST RESISTANCE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE, DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. TORQUING THE GUIDEWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE WHICH MAY RESULT IN SEPARATION OF THE DISTAL TIP. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. TIP FRACTURES HAVE BEEN REPORTED IN PROCEDURES INVOLVING TOTAL OCCLUSIONS, HIGHLY TORTUOUS VASCULATURE, AND SMALL SIDE BRANCHES. DO NOT PULL THE DISTAL TIP TO REMOVE GUIDEWIRE FROM DISPENSER AS IT MAY DAMAGE THE TIP. GENTLY INTRODUCE AND ADVANCE THE GUIDEWIRE TO PREVENT DAMAGING THE DISTAL TIP.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AFTER FURTHER REVIEWED OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY : THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT# 35262179 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
A 4.5 F NON -CORDIS SHEATH WAS INSERTED FROM THE JUGULAR REGION. TWO NON-CORDIS 014 GUIDEWIRES CROSSED THE LESION. A NON-CORDIS BALLOON CATHETER FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)WAS INSERTED BUT IT WAS UNABLE TO BE DELIVERED DUE TO SEVERE TORTUOUS AT THE RIGHT PULMONARY ARTERY (PA). TO EMPHASIS SUPPORT, ONE OF THE PGW .018 SV SHORT 180CM ST WIRES WAS USED. IT WAS USED TOGETHER WITH A NON -CORDIS MICROCATHETER. ONE OF THEM WAS USED BUT IT BROKE WHEN IT WAS ATTEMPTED TO BE SHAPED CURVE OUTSIDE THE PATIENT. THE DISTAL END OF THE GUIDEWIRE WAS BROKEN, AND THE COIL PART UNRAVELED BY PULLING THE DISTAL WIRE WITH HAND(S). IT WAS REPLACED WITH ANOTHER PGW .018 SV SHORT 180CM ST. THE DISTAL END WAS SHAPED CURVE AND IT CROSSED THE LESION. THE NON -CORDIS BALLOON CATHETER WAS DELIVERED BUT IT WAS DIFFICULT FOR IT TO CROSS THE TORTUOUS RIGHT PULMONARY ARTERY (PA) AND STENT IMPLANTED REGION. THE PHYSICIAN RETRACTED THE PGW .018 SV SHORT 180CM ST GUIDEWIRE BUT THE DISTAL END OF THE COIL DID NOT MOVE. THE PHYSICIAN SUSPECTED THE COIL IS UNRAVELED. THE PGW .018 SV SHORT 180CM ST GUIDEWIRE WAS SLOWLY RETRACTED THE GUIDEWIRE GOT SEPARATED AND THE COIL PART GOT STRETCHED. IT REMAINED IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE BUT IT WAS DIFFICULT THEREFORE, THE PROCEDURE COMPLETED AS IT WAS ON THE DAY. AFTER THIS PROCEDURE, THE COIL PART OF THE FIRST PGW .018 SV SHORT 180CM ST GUIDEWIRE WAS SLIGHTLY RETRACTED TO CONFIRM POSSIBILITY OF UNRAVELING THE PGW .018 SV SHORT 180CM ST GUIDEWIRE BUT IT GOT STRETCHED EASILY. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PEDIATRIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). UNKNOWN STENT(S) WERE IMPLANTED AT THE PA MAIN BLOOD VESSEL AND THE RIGHT PA. THE STENT DISTAL END OF THE RIGHT PA HAD LESION. THE TARGET SITE WAS THE DISTAL END OF THE RIGHT PULMONARY ARTERY. THE ACCESS SITE WAS IN THE JUGULAR REGION., THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. A CONTRALATERAL APPROACH WAS NOT USED, IT WAS MADE FROM THE RIGHT PULMONARY ARTERY. VESSEL CHARACTERISTICS AT TARGET SITE, SHOWED MODERATE TORTUOSITY AND ACUTE ANGLE. THERE WAS 90% STENOSIS NOTED. THE DEVICE WAS NOT BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. NO PROCEDURAL CD ARE AVAILABLE FOR REVIEW. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508053 | PGW .018 SV SHORT 180CM ST | WIRE, GUIDE, CATHETER | DQX | CORDIS CORPORATION | 503558 | 35262179 | 10705032056052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | (2 )014 GUIDEWIRES (SION BLUE) (SION BLUE ES).| UNK BALLOON CATHETER.| UNK MICROCATHETER.| UNK SHEATH (4.5F).| UNK STENTS. |