DGW .035 MC J3MM 150CM TEF
Report
- Report Number
- 1016427-2018-02368
- Event Type
- Injury
- Date Received
- December 26, 2018
- Date of Event
- November 29, 2018
- Report Date
- April 10, 2019
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQX
- PMA / PMN Number
- K864058
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
DURING FAL, IT WAS DETERMINED THAT TWO OF THE THREE WIRES EXHIBITED A FRACTURED SEPARATED CONDITION AND THE THIRD WIRE WAS KINKED. THEREFORE, GUIDEWIRE - SEPARATED WAS ADDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING THE PROCEDURE, IT WAS REPORTED THAT THE COAT OF TWO PTFE EMERALD GUIDE WIRE GOT AWAY FROM THE WIRES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS NOTED THAT THREE DEVICES WERE INVOLVED, THE THIRD DEVICE WAS KINKED. THE TARGET LESION WAS CALCIFIED AND WAS NOT A CHRONIC TOTAL OCCLUSION IN THE PAST THREE MONTHS. THE EMERALD WIRES WERE NOT RESTERILIZED. THE WIRES WERE NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THERE WERE NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION OF THE WIRES INTO THE PATIENT. THE WIRES WERE NOT RESHAPED BY THE USER. THE WIRES WEREN'T USE FOR ANY OTHER PROCEDURE. A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WAS NOT USED TO RECANALIZE THE VESSEL. THERE WAS NO DIFFICULTY TRACKING THE WIRES THROUGH THE LESION AND THE WIRES DID BEHAVE NORMALLY WITH GOOD TORQUE RESPONSE. THERE WAS NO RESTRICTION FRICTION BETWEEN ANY OTHER DEVICES. THE WIRES DID NOT TRACK THROUGH A PREVIOUSLY PLACED STENT. THE WIRE TIPS DID NOT REPEATEDLY PROLAPSE DURING PLACEMENT. THE DEVICES ARE AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED. DURING FAL, IT WAS DETERMINED THAT TWO OF THE THREE WIRES EXHIBITED A FRACTURED SEPARATED CONDITION AND THE THIRD WIRE WAS KINKED. ATTEMPTS AT ADDITIONAL INFORMATION WAS UNSUCCESSFUL. TWO NON-STERILE GUIDE WIRES DGW .035 FC J3MM 150CM TEF ALONG WITH ONE NON-STERILE GUIDEWIRE DGW .035 FC J3MM 260CM TEF WERE RECEIVED COILED INSIDE A PLASTIC BAG. NO ORIGINAL PACKAGING WAS RECEIVED. PER VISUAL ANALYSIS FOR UNIT NUMBER TWO, A FRACTURE/SEPARATION CONDITION WAS NOTED ON THE COILED WIRE FROM PROXIMAL SECTION. THE SEPARATED GUIDE WIRE PORTIONS WERE IDENTIFIED AS GUIDE WIRE PORTION 2A AND GUIDEWIRE PORTION 28. NO OTHER DAMAGES/ANOMALIES WERE NOTED. A SEM ANALYSIS WAS REQUIRED TO IDENTIFY THE ROOT CAUSE OF THE SEPARATION/FRACTURE FOUND. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 11018118 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE PHR REVIEW DOES NOT SUGGEST THAT THE EVENT REPORTED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THE SECTIONS OF THE COILED WIRES SEPARATIONS WERE SCANNED UNDER THE SEM STATION IN ORDER TO DETERMINE THE ROOT CAUSE OF THE SEPARATIONS. THE COILED WIRES WERE IDENTIFIED AS SAMPLE NUMBER TWO SECTION A (2A) AND SAMPLE NUMBER TWO SECTION B (2B) TO PERFORM THE SEM ANALYSIS. SEM RESULTS FOR SAMPLE 2A SHOW EVIDENCE OF CUTTING, SMEARING AND AT A LESSER EXTENT DUCTILE DIMPLES, ON THE SEPARATED AREA IN THE COILED WIRE. SAMPLE 2B, ONLY SMEARING ON THE SURFACE OF THE SEPARATED AREA OF COILED WIRE COULD BE NOTED. COMMONLY, DUCTILE DIMPLES SUGGEST A DEVICE MANIPULATION THAT LEADS THE MATERIAL TO SEPARATION; HOWEVER, SINCE CUTTING CONDITIONS WERE NOTED, IT IS SUGGESTED THAT THE FRACTURE COULD BE RELATED, AT LEAST INITIALLY, TO THE INTERACTION OF A SHARP OBJECT WITH THE WIRE MATERIAL FOLLOWED BY PULLING AND/OR REVERSE BENDING EVENTS, WHICH WOULD TRANSLATE IN SEPARATION AND SMEARING OF THE SURFACES. NO OTHER ISSUES WERE FOUND DURING THE SEM ANALYSIS. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿COATING-WIRES- DELAMINATED - IN PATIENT¿ WAS NOT CONFIRMED. HOWEVER, THE REPORTED FAILURE AS "GUIDEWIRE-FRACTURED/SEPARATED" WAS CONFIRMED DUE TO THE SEPARATION/FRACTURE FOUND ON THE GUIDE WIRE FROM PROXIMAL SECTION. SEM RESULTS SHOWED CUTTING CONDITIONS, IT IS SUGGESTED THAT THE FRACTURE COULD BE RELATED, AT LEAST INITIALLY, TO THE INTERACTION OF A SHARP OBJECT WITH THE WIRE MATERIAL FOLLOWED BY PULLING AND/OR REVERSE BENDING EVENTS, WHICH WOULD TRANSLATE IN SEPARATION AND SMEARING OF THE SURFACES. ADDITIONAL TO THIS, EVIDENCE OF DUCTILE DIMPLES ON THE COILED WIRE AT THE SEPARATED AREA WERE NOTED. EVIDENCE OF A CUTTING PATTERN ON THE CORE WIRE WAS ALSO FOUND. NEITHER PHR REVIEW RESULTS NOR PRODUCT EVALUATION NOR SEM RESULTS SUGGEST THAT THE SEPARATION FOUND IS RELATED TO THE MANUFACTURING PROCESS. THE REPORTED ¿COATING-WIRES- DELAMINATED - IN PATIENT¿ WAS NOT CONFIRMED IN DEVICES ONE AND TWO, PRODUCT EVALUATION FOR DEVICE THREE IS PENDING. HOWEVER, A SEPARATION/FRACTURE CONDITION WAS FOUND ON THE GUIDEWIRES. SEM RESULTS SHOWED THAT CUTTING CONDITIONS WERE NOTED, IT IS SUGGESTED THAT THE FRACTURE COULD BE RELATED, AT LEAST INITIALLY, TO THE INTERACTION OF A SHARP OBJECT WITH THE WIRE MATERIAL FOLLOWED BY PULLING AND/OR REVERSE BENDING EVENTS, WHICH WOULD TRANSLATE IN SEPARATION AND SMEARING OF THE SURFACES. ADDITIONAL TO THIS, EVIDENCE OF DUCTILE DIMPLES ON THE COILED WIRE AT THE SEPARATED AREA CAN BE OBSERVED. EVIDENCE OF A CUTTING PATTERN ON THE CORE WIRE WAS ALSO FOUND. HANDLING/PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO THIS DAMAGE. AS PER THE PRECAUTIONS IN THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. USE PRIOR TO ¿USE BY¿ DATE. DO NOT EXPOSE TO ORGANIC SOLVENTS. EXPOSURE TO TEMPERATURES ABOVE 54OC (130OF) MAY DAMAGE THE COMPONENTS. DO NOT WITHDRAW A PTFE COATED GUIDEWIRE THROUGH A METAL-CANNULA NEEDLE. WITHDRAWAL MAY DAMAGE THE GUIDEWIRE COATING. IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE.¿ NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED AND SECTION B5 "DESCRIPTION OF EVENT" AND SECTION D10 WERE UPDATED. THIS DEVICE WAS RECEIVED FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION WAS RECEIVED AND THE TARGET LESION WAS CALCIFIED AND WAS NOT A CHRONIC TOTAL OCCLUSION IN THE PAST THREE MONTHS. THE EMERALD WIRE'S WERE NOT RESTERILIZED. THE WIRES WERE NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THERE WERE NO KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION OF THE WIRES INTO THE PATIENT. THE WIRES WERE NOT RESHAPED BY THE USER. THE WIRES WEREN'T USE FOR ANY OTHER PROCEDURE. A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WAS NOT USED TO RECANNULIZE THE VESSEL. THERE WAS NO DIFFICULTY TRACKING THE WIRES THROUGH THE LESION AND THE WIRES DID BEHAVE NORMALLY WITH GOOD TORQUE RESPONSE. THERE WAS NO RESTRICTION FRICTION BETWEEN ANY OTHER DEVICES. THE WIRES DID NOT TRACK THROUGH A PREVIOUSLY PLACED STENT. THE WIRE TIPS DID NOT REPEATEDLY PROLAPSE DURING PLACEMENT. THE DEVICES ARE AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING THE PROCEDURE, IT WAS REPORTED THAT THE COAT OF THE PTFE EMERALD WIRE GOT AWAY FROM THE WIRE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1034819 | DGW .035 MC J3MM 150CM TEF | WIRE, GUIDE, CATHETER | DQX | CORDIS CORPORATION | 502571 | 35235740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Life Threatening |