SGW .014 WIZDOM SOFT 180 ST
Report
- Report Number
- 1016427-2019-03175
- Event Type
- Injury
- Date Received
- August 19, 2019
- Date of Event
- July 23, 2019
- Report Date
- October 7, 2019
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQX
- PMA / PMN Number
- K873403
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
COMPLAINT CONCLUSION: AS REPORTED, THE PHYSICIAN TRIED TO ACCESS THE BRACHIAL VEIN WHICH WAS A LITTLE TORTUOUS. RESISTANCE WAS MET AND THE PHYSICIAN TRIED TO WITHDRAW THE WIZDOM WIRE (SGW .014 WIZDOM SOFT 180 ST). WHILE TRYING TO REMOVE THE WIRE, THE TIP OF THE WIRE SHEARED OFF IN THE CEPHALIC VEIN. THERE WAS NO REPORTED PATIENT INJURY. PROPER PREP WAS PERFORMED IN A STERILE FIELD. THE PRODUCT WAS CLINICALLY USED. THE PRODUCT WAS NOT RESTERILIZED. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT KINKED NOR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE VESSEL WAS NOT CALCIFIED, HAD NO STENOSIS NOR BIFURCATION. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (100% OCCLUSION FOR > 3 MONTHS). A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WAS NOT USED TO RECANNULIZE THE VESSEL. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THE WIRE BEHAVED ¿NORMALLY.¿ THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES DURING INSERTION, OR WITHDRAWAL INTO ANOTHER DEVICE. THE WIRE DID NOT KINK WHILE BEING USED. THE WIRE WAS NOT ADVANCED THROUGH THE STRUTS OF AN EXISTING STENT. THE WIRE TORQUED AGAINST RESISTANCE UPON REMOVAL. THEY PHYSICIAN FELT THAT IT WAS NOT NECESSARY TO REMOVE THE SEPARATED SEGMENT. THE PROCEDURE WAS COMPLETED THROUGH DIFFERENT ACCESS. THE PATIENT HAS BEEN DISCHARGED. A NON-STERILE UNIT OF A WIZDOM GUIDEWIRE (SGW .014 WIZDOM SOFT 180 ST) WAS RECEIVED COILED INSIDE OF A CLEAR PLASTIC BAG. PER VISUAL ANALYSIS, A SEPARATION CONDITION WAS OBSERVED AT THE DISTAL TIP. THE SEPARATED FRAGMENT WAS NOT RETURNED FOR ANALYSIS. NO OTHER DAMAGES OR ANOMALIES WERE NOTICED. DURING MICROSCOPIC ANALYSIS, THE SEPARATED AREA OF THE BODY OF THE SGW .014 WIZDOM SOFT 180 ST UNIT PRESENTED EVIDENCE OF DIAMETER REDUCTION, TENSION MARKS, AND PLASTIC DEFORMATION RESULTING IN CUP AND CONE-LIKE SHAPES ON THE WIRE. THE PLASTIC DEFORMATIONS AS WELL AS THE CUP-LIKE SURFACE FOUND ON THE WIRE, RESULTING IN A DIAMETER REDUCTION AND TENSION MARKS, ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE GUIDEWIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. NO OTHER ANOMALIES WERE OBSERVED DURING SEM ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35236282 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿GUIDEWIRE - WITHDRAWAL DIFFICULTY FROM VESSEL¿ COULD NOT BE PROPERLY EVALUATED DUE TO THE SEPARATED CONDITION OBSERVED ON THE DISTAL TIP. THE CAUSE OF THE REPORTED EVENT BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿DISTAL TIP-WIRES¿FRACTURED-SEPARATED-IN PATIENT¿ WAS CONFIRMED, AS A SEPARATION CONDITION WAS OBSERVED AT THE DISTAL TIP. THE CAUSE OF THIS DAMAGE REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. THE PLASTIC DEFORMATIONS AS WELL AS CUP-LIKE SURFACE FOUND ON THE WIRE, RESULTING IN A DIAMETER REDUCTION AND TENSION MARKS, ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE GUIDEWIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. PROCEDURAL/HANDLING FACTORS AND/OR VESSEL CHARACTERISTICS MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENTS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, ¿GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. GENTLY INTRODUCE AND ADVANCE THE GUIDEWIRE TO PREVENT DAMAGING THE DISTAL TIP. TO AID IN THE NAVIGATION WITHIN AND SELECTION OF ARTERIES, THE GUIDEWIRE MAY BE RESHAPED. TO AID IN ROTATING OR STEERING THE GUIDEWIRE, SECURE A STEERING DEVICE TO THE PROXIMAL END OF THE GUIDEWIRE. CAUTION: TO PREVENT VESSEL INJURY OR TIP ENTRAPMENT, USE FLUOROSCOPY WHEN ADVANCING/TORQUING THE GUIDEWIRE. USE ACCEPTED ANGIOGRAPHIC TECHNIQUE FOR GUIDEWIRE POSITIONING. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. IF THE TIP BECOMES FIXED WITHIN THE VASCULATURE, ADVANCE THE BALLOON CATHETER AS DISTALLY AS POSSIBLE, GENTLY PULL THE GUIDEWIRE BACK INTO THE BALLOON CATHETER AND WITHDRAW THE BALLOON CATHETER/GUIDEWIRE SYSTEM AS A UNIT - NEVER TORQUE THE GUIDEWIRE IF THE TIP BECOMES FIXED.¿ NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE OBSERVED DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
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 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.
AS REPORTED, THE PHYSICIAN TRIED TO ACCESS THE BRACHIAL VEIN WHICH WAS A LITTLE TORTUOUS. RESISTANCE WAS MET AND THE PHYSICIAN TRIED TO WITHDRAW THE WIZDOM WIRE (SGW .014 WIZDOM SOFT 180 ST). WHILE TRYING TO REMOVE THE WIRE, THE TIP OF THE WIRE SHEARED OFF IN THE CEPHALIC VEIN. THERE WAS NO REPORTED PATIENT INJURY. PROPER PREP WAS PERFORMED IN STERILE FIELD. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE PRODUCT WAS NOT RESTERILIZED. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT KINKED NOR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE VESSEL WAS NOT CALCIFIED, HAD NO STENOSIS NOR BIFURCATION. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (100% OCCLUSION FOR > 3 MONTHS). A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WAS NOT USED TO RECANNULIZE THE VESSEL. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THE WIRE BEHAVED ¿NORMALLY¿. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE AND OTHER DEVICES DURING INSERTION, OR WITHDRAWAL INTO ANOTHER DEVICE. THE WIRE DID NOT KINK WHILE BEING USED. THE WIRE WAS NOT ADVANCED THROUGH THE STRUTS OF AN EXISTING STENT. THE WIRE TORQUED AGAINST RESISTANCE UPON REMOVAL THEY PHYSICIAN FELT THAT IT WAS NOT NECESSARY TO REMOVE THE SEPARATED SEGMENT. THE PROCEDURE WAS COMPLETED THROUGH DIFFERENT ACCESS. THE PATIENT HAS BEEN DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702459 | SGW .014 WIZDOM SOFT 180 ST | WIRE, GUIDE, CATHETER | DQX | CORDIS CORPORATION | 512142 | 35236282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Life Threatening |