ENROUTE,ST,MOD,S,HY,US 95-014
Report
- Report Number
- 3006010712-2024-00031
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- May 30, 2024
- Report Date
- July 3, 2024
- Manufacturer
- LAKE REGION MEDICAL
- Product Code
- DQX
- UDI-DI
- 00811311020546
- PMA / PMN Number
- K160643
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, LIMITED INVESTIGATION WAS CARRIED OUT. NO SAMPLE RETAIN OF THE SAME LOT NUMBER WAS AVAILABLE. THE DEVICE LOT HISTORY RECORDS HAVE BEEN REVIEWED, AND IT IS SHOWN THAT THERE WERE NO ANOMALIES OR NON-CONFORMANCE RAISED THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE AND THAT THE GUIDEWIRES WERE MANUFACTURED ACCORDING TO THE SPECIFICATION. ALL THE REQUIRED RELEVANT TESTS AND INSPECTIONS WERE PERFORMED AND PASSED. THE RISK TRACEABILITY MATRIX NUMBER RMF(TM)-003 WAS REVIEWED AND IT WAS FOUND THAT THE RISK FOR THIS FAILURE MODE WAS INCLUDED AND WELL DOCUMENTED. THE CURRENT RATING FOR THE FAILURE MODE IN QUESTION IS BELOW THE EXPECTED LEVELS FOR THE CONFIRMED COMPLAINTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DESIGN OF THE GUIDEWIRE OR ANY MANUFACTURING-RELATED CONCERNS HAS CONTRIBUTED TO THE INCIDENT AS WELL AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, THUS THE COMPLAINT CAUSE CANNOT BE VERIFIED. ADDITIONAL CONTAINMENT: NO ADDITIONAL CONTAINMENT REQUIRED. A LOT HISTORY RECORDS REVIEW WAS CARRIED OUT ON THE FINISHED GOOD LOT NUMBER 8007119 AND THE SUB-ASSEMBLY LOT NUMBERS 7571640, 8041749, 8089061. THE RISK TRACEABILITY MATRIX RMF(TM)-003, REV. 6, LISTS: · "VESSEL PERFORATION/DISSECTION" AS A HAZARD/HAZARDOUS SITUATION CAUSED BY "ADVANCEMENT ISSUES NOTED FOR CAROTID VASCULATURE (TCAR PROCEDURE)" - LINE 77.0 THE LOT HISTORY RECORDS REVIEW WAS CARRIED OUT WHICH FOCUSED ON KEY MANUFACTURING CONTROLS TO PREVENT THE HAZARD/HAZARDOUS SITUATION OCCURRING. A) PTFE COATING: THE GUIDEWIRES WERE MANUFACTURED ACCORDING TO PROCEDURES SOP992 (MULTICHAMBER CLEANING SYSTEM AND QTC CLEANING), EWIPTFE (PTFE COATING PROCESS OPERATING INSTRUCTIONS), EWIPTFEOVEN (PTFE CURING OVEN OPERATING INSTRUCTIONS) AND INSPECTED ACCORDING TO THE PROCEDURES SOP870 (PTFE COATING OF COREWIRES) AND SOP815 (STRAIGHTENED, PTFE COATED CORE WIRE- FINAL INSPECTION). THE GUIDEWIRES PASSED ALL THE REQUIRED INSPECTIONS AND TESTS. IN RELATION TO THE PTFE COATING THE FOLLOWING WERE PERFORMED AND PASSED: 100% POST COATING VISUAL INSPECTION; 100% POST COATING DIMENSIONAL INSPECTION; PTFE COATING TACTILE TEST; PTFE COATING WRAP TEST; PTFE COATING ADHESION TEST. A) SOLDERING: THE WORK ORDER OF THE FINAL ASSEMBLY LOT NUMBER 8007119 WAS REVIEWED. IT WAS CONFIRMED THAT SOLDERING WAS CARRIED OUT AS PER SOP603 (GUIDEWIRE DISTAL SOLDERING), SOP613 (GUIDEWIRE PROXIMAL AND COIL TO CORE SOLDERING), SOP968 (SOLDERING PROCEDURE) AND SOP615 (GUIDEWIRE FINAL INSPECTION). 100% OF INLINE PULL TEST OF THE SOLDER JOINTS FOR GUIDEWIRES WAS CARRIED OUT AS PER THE PROCEDURE SOP613 (GUIDEWIRE PROXIMAL AND COIL TO CORE SOLDERING). A 100% INSPECTION OF SOLDER JOINT DIAMETER TOOK PLACE. ALL GUIDEWIRES PASSED THE DIMENSIONAL INSPECTION WITH NO ISSUE REPORTED. ALL SOLDER JOINTS WERE WITHIN DIMENSIONAL SPECIFICATION. PER RISK TRACEABILITY MATRIX RMF(TM)-003 THE GUIDEWIRE TIP IS DESIGNED TO BE ATRAUMATIC, A 100% VISUAL INSPECTION DURING SOLDER PROCESS VERIFIED ALL DEVICES HAD A ROUNDED TIP. B) COILING: THE COILS WERE MANUFACTURED AND INSPECTED ACCORDING TO THE PROCEDURES SOP600 (COIL WINDER). THE MATERIALS USED TO MANUFACTURE A COIL WERE INSPECTED AND IT WAS CONFIRMED THAT THE CORRECT PART NUMBERS WERE USED DURING THE MANUFACTURING PROCESS. THE COIL PITCH WAS FOUND TO BE WITHIN THE SPECIFICATION. C) CORE FLATTENING: IN RELATION TO THE CORE FLATTENING MEASUREMENTS, THE FINISHED DEVICE LOT NUMBER 8007119 WAS REVIEWED AND FOUND THAT ALL INSPECTION HAD TAKEN PLACE AND THE LOT WAS MANUFACTURED ACCORDING TO THE SPECIFICATION FOR FLAT THICKNESS AND LENGTH. THE LOT WAS MANUFACTURED ACCORDING TO THE PROCEDURE SOP601 (CORE FLATTENING OPERATION) WITH NO ISSUE REPORTED. D) CORE GRINDING: IN RELATION TO GRIND DIMENSIONS, THE WORK ORDER OF THE SUB-ASSEMBLY LOT NUMBER 7571640 WAS REVIEWED AND FOUND THAT ALL INSPECTIONS HAD TAKEN PLACE AND THE LOT WAS MANUFACTURED ACCORDING TO THE SPECIFICATION FOR ALL LENGTH, DIAMETER, AND TAPER MEASUREMENTS. IT WAS FOUND THAT THE LOTA WAS MANUFACTURED ACCORDING TO THE PROCEDURE SOP621 (DISTAL GRINDING OPERATION). E) HYDROPHILIC COATING: THE GUIDEWIRES WERE MANUFACTURED AND INSPECTED ACCORDING TO THE PROCEDURES SOP605 (GUIDEWIRE COATING PROCEDURE). IN RELATION TO THE HYDROPHILIC COATING THE FOLLOWING WERE PERFORMED AND PASSED: 100% DIMENSIONAL AND VISUAL INSPECTION OF COATING AT THE POST COATING INSPECTION STEP WAS CARRIED OUT AS PER THE PROCEDURE SOP607. THE GUIDEWIRES PASSED THE INSPECTION. THE SAMPLES TAKEN IN THE MANUFACTURING PROCESS PASSED THE LUBRICITY AND CONGO RED TESTS. THE TENSILE AND TORQUE FATIGUE TESTS WERE COMPLETED AND MET SPECIFICATION FOR THE LOT IN QUESTION. THE LOT HISTORY RECORDS WERE REVIEWED FOR ANY VARIATION PERMITS (VP'S), TEMPORARY DEVIATIONS (TD'S) OR NON-CONFORMANCE REPORTS (NCR'S) THAT MAY HAVE CONTRIBUTED TO THE INCIDENT. THERE WERE NO DEVIATIONS (VP'S/TD'S) AND NO NON-CONFORMING MATERIAL REPORTS (NCR'S) APPLIED TO ANY FINISHED GOOD OR SUB-ASSEMBLY LOTS WHICH COULD HAVE CONTRIBUTED TO THE INCIDENT. THE FINISHED GOOD LOT WAS MANUFACTURED ON THE 20-FEB-2024 AND ITS EXPIRY DATE IS THE 31-JAN-2024. BASED ON THE LOT HISTORY RECORD REVIEW, IT IS CONCLUDED THAT THE GUIDEWIRES WERE MANUFACTURED ACCORDING TO THE SPECIFICATION. THE REQUIRED TESTS AND INSPECTIONS WERE PERFORMED AND PASSED. RISK ASSESSMENT: THE RISK TRACEABILITY MATRIX NUMBER RMF(TM)-003 REV. 6 LINE 77.0 WAS REVIEWED: "VESSEL PERFORATION/DISSECTION" AS A HAZARD/HAZARDOUS SITUATION CAUSED BY "ADVANCEMENT ISSUES NOTED FOR CAROTID VASCULATURE (TCAR PROCEDURE)" - LINE 77.0. ANALYSIS OF THE FAILURE MODE FOR THE HAZARD/HAZARDOUS SITUATION IN QUESTION DEMONSTRATES AN OCCURRENCE RATING OF 4 AND A SEVERITY RATING OF 4. ACCORDING TO THE PRO-001833 [?]RISK MANAGEMENT PROCEDURE'; REV. D AN OCCURRENCE RATING OF 4 EQUATES TO A [?]REASONABLY PROBABLE' PROBABILITY OF OCCURRENCE OF THIS HAZARDOUS SITUATION BETWEEN [?]1250 PPM AND <5000 PPM. THE CURRENT RATING OF 13 FOR CONFIRMED COMPLAINTS IS BELOW THE EXPECTED LEVELS. ACCORDING TO THE RMF(TM)-003, THE RISK CONTROL MEASURES FOR THIS INSTANCE ARE AS FOLLOWS: RECEIVING INSPECTION (REF. QI006); CORE STRAIGHTENING AND HEAT TREATMENT (SOP802); PTFE COATING (REF. SOP870, SOP992, EWIPTFE, EWIPTFEOVEN); SOLDERING (REF. SOP603); COILING (REF. SOP600); CORE GRINDING (REF. SOP621); HYDROPHILIC COATING (REF. SOP605). CORE MATERIAL PROPERTIES; CORE GRIND DIMENSIONS; TIP COIL SPACING; TIP FLATTENING DIMENSIONS; COIL. GUIDEWIRE IS DESIGNED TO WITHSTAND NORMAL FORCES EXPERIENCED DURING ITS INTENDED USE. GUIDEWIRE IS DESIGNED TO MEET TURNS TO FAILURE SPECIFICATION OF 10 TURNS MINIMUM; GUIDEWIRE TIP IS DESIGNED TO BE ATRAUMATIC (ROUNDED TIP DURING SOLDERING PROCESS); TIP STIFFNESS PROPERTIES DESIGNED TO BE EQUIVALENT TO THE MARKETED PREDICATE DEVICE. THE WARNING SECTION OF THE IFU STATES: "A GUIDEWIRE IS A DELICATE INSTRUMENT AND MUST NOT BE ADVANCED, WITHDRAWN, OR TORQUED IF RESISTANCE IS MET. GUIDEWIRE MANIPULATIONS MUST ALWAYS BE OBSERVED UNDER FLUOROSCOPY" (REF. DFU-0069).
COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED IN THE COMMON CAROTID ARTERY WHILE INSERTING THE ENROUTE 0.014" GUIDEWIRE. THE 0.014" GUIDEWIRE APPEARED TO PROLAPSE WITHIN THE VESSEL. THE PHYSICIAN REPOSITIONED THE ARTERIAL SHEATH AND THE WIRE ADVANCED WITHOUT ISSUE. AN UNPLANNED ADDITONAL STENT WAS PLACED TO COVER THE DISSECTION.
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, A DISSECTION WAS IDENTIFIED IN THE COMMON CAROTID ARTERY WHILE INSERTING THE ENROUTE 0.014" GUIDEWIRE. THE 0.014" GUIDEWIRE APPEARED TO PROLAPSE WITHIN THE VESSEL. THE PHYSICIAN REPOSITIONED THE ARTERIAL SHEATH AND THE WIRE ADVANCED WITHOUT ISSUE. AN UNPLANNED ADDITONAL STENT WAS PLACED TO COVER THE DISSECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2194653 | ENROUTE,ST,MOD,S,HY,US 95-014 | ENROUTE,ST,MOD,S,HY,US 95-014 | DQX | LAKE REGION MEDICAL | 901047-01 | 8007119 | 00811311020546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |