PROWLER MICROCATHETERS
Report
- Report Number
- 1058196-2010-00367
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 22, 2010
- Report Date
- November 24, 2010
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- KRA
- PMA / PMN Number
- K993266
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2010-00366 AND 1058196-2010-00367. ADDITIONAL INFORMATION 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. REVIEW OF LOT 13470905 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS OR EXCURSIONS WERE ISSUED FOR THIS LOT 13470905. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00366 AND 1058196-2010-00367. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
A NON-STERILE PROWLER PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. IT WAS INSPECTED AND KINKS WERE FOUND "O IT". THE DISTAL BODY WAS INSPECTED AND COMPRESSED/FLAT SECTIONS WERE FOUND ON IT. HUB WAS INSPECTED AND NO ANOMALIES WERE FOUND. THE ID OF THE MICROCATHETER WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATION. THE DISTAL BODY OF THE MICROCATHETER WAS INSPECTED UNDER MICROSCOPE AND THE COMPRESSED/FLAT SECTIONS FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED. A GUIDEWIRE .018 (CORDIS - LAB SAMPLE), WAS INTRODUCED IN TO THE MICROCATHETER FROM HUB BUT IT WAS STUCK IN THE PROXIMAL BODY, THE GUIDEWIRE WAS REMOVED FROM THE DEVICE, AFTER THAT THE GUIDEWIRE WAS INTRODUCED THROUGH THE DISTAL TIP AND EVEN THE DAMAGE PRESENTED ON THE DEVICE THE GUIDEWIRE COULD PASS THROUGH IT; HOWEVER THE GUIDE WIRE WAS STUCK IN THE PROXIMAL BODY. THE MICROCATHETER WAS CUT IN THE STUCK AREA AND ONE EMBOLIC COIL (NON-CORDIS COIL) WAS EXPOSED, THE EMBOLIC COIL WAS FOUND STUCK IN ONE OF THE KINKS FOUND IN THE PROXIMAL BODY, THE EMBOLIC COIL WAS REMOVED FROM THE UNIT, AFTER THAT THE GUIDEWIRE WAS INSERTED AGAIN FROM THE DISTAL END AND EVEN THE DAMAGE PRESENTED ON THE DEVICE, IN THIS NEW ATTEMPT THE GUIDE WIRE COULD PASS THROUGH THE MICROCATHETER. 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. THE FAILURE REPORTED BY THE CUSTOMER AS "CATHETER - OBSTRUCTED" WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER WAS DUE TO ONE EMBOLIC COIL (NON-CORDIS) WAS STUCK IN THE DEVICE, THE EMBOLIC COIL WAS STUCK IN THE DEVICE DUE TO ONE KINK FOUND ON IT, THE CAUSE OF THE KINKS AND COMPRESSED/FLAT SECTION COULD NOT BE CONCLUSIVELY DETERMINED; NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED OR THE COMPRESSED/FLAT SECTIONS FOUND ON THE MICROCATHETER COULD BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONAL INSPECTIONS ARE IN PLACE ((B)(4)) THAT PREVENTS THESE KIND OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL FACTORS APPEAR TO BE CONTRIBUTED IN THE EVENT REPORTED AND THE DAMAGES FOUND; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00366 AND 1058196-2010-00367. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE OF AN UNKNOWN TARGET SITE OR PROCEDURE TYPE, 2MMX5CM COILS (VORTEX, BOSTON SCIENTIFIC) WERE DELIVERED IN TWO PROWLER SELECT MICROCATHETERS (B)(4) USING BOSTON SCIENTIFIC COIL PUSHERS BUT THE COILS WERE STUCK IN THE PROWLER MICROCATHETERS. THE MICROCATHETERS WERE REMOVED AND ANOTHER NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. NO DAMAGES WERE NOTED ON THE MICROCATHETERS THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND THE MICROCATHETERS WERE FLUSHED AFTER EVERY COIL WAS DELIVERED. THERE WAS NO INFORMATION REGARDING THE VESSEL CHARACTERISTICS. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE PROWLER PLUS MICROCATHETER (MC) WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. IT WAS INSPECTED AND KINKS WERE FOUND O IT. THE DISTAL BODY WAS INSPECTED AND COMPRESSED/FLAT SECTIONS WERE FOUND ON IT. HUB WAS INSPECTED AND NO ANOMALIES WERE FOUND. THE ID OF THE MC WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATION. THE DISTAL BODY OF THE MC WAS INSPECTED UNDER MICROSCOPE AND THE COMPRESSED/FLAT SECTIONS FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED. A CORDIS LAB SAMPLE 0.018" GUIDEWIRE (GW) WAS INTRODUCED IN TO THE MC FROM THE HUB BUT IT WAS STUCK IN THE PROXIMAL BODY. THE GW WAS REMOVED FROM THE DEVICE. THE GW WAS THEN INTRODUCED THROUGH THE DISTAL TIP AND EVEN WITH THE DAMAGE PRESENTED ON THE DEVICE THE GW COULD PASS THROUGH IT; HOWEVER THE GW WAS STUCK IN THE PROXIMAL BODY. THE MC WAS CUT AT THE AREA THAT THE GW BECAME STUCK AREA AND ONE EMBOLIC COIL WAS EXPOSED. THE EMBOLIC COIL WAS FOUND STUCK IN ONE OF THE KINKS FOUND IN THE PROXIMAL BODY. THE EMBOLIC COIL WAS REMOVED FROM THE UNIT, AFTER THAT THE GW WAS INSERTED AGAIN FROM THE DISTAL END AND EVEN THE DAMAGE PRESENTED ON THE DEVICE, IN THIS NEW ATTEMPT THE GUIDE WIRE COULD PASS THROUGH THE MC. 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. THE REPORTED OBSTRUCTION OF THE PROWLER SELECT MICROCATHETER WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE REPORTED EVENT WAS DUE TO ONE EMBOLIC COIL (REPORTED AS A BOSTON SCIENTIFIC VORTEX) BEING STUCK IN THE DEVICE AT A KINKED AREA. THE CAUSE OF THE KINKS AND COMPRESSED/FLAT SECTION COULD NOT BE CONCLUSIVELY DETERMINED. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. PROCEDURAL FACTORS AND INTERACTION WITH THE CONCOMITANT DEVICE APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT AND DAMAGES FOUND. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00366 AND 1058196-2010-00367.
DURING A COIL EMBOLIZATION PROCEDURE OF AN UNKNOWN TARGET SITE OR PROCEDURE TYPE, 2MMX5CM COILS (VORTEX, BOSTON SCIENTIFIC) WERE DELIVERED IN TWO MICROCATHETERS 606-2511 (COMPLAINT PRODUCTS) WITH THE COIL PUSHERS (DETAIL UNKNOWN, BOSTON SCIENTIFIC), BUT THE COILS WERE STUCK IN THE MICROCATHETERS. THE MICROCATHETERS WERE REMOVED AND THE ANOTHER NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. NO DAMAGES WERE NOTED ON THE MICROCATHETERS THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND THE MICROCATHETERS WERE FLUSHED AFTER EVERY COIL WAS DELIVERED. BOTH COILS WERE BOSTON SCIENTIFIC PRODUCTS. THERE WAS NO INFORMATION REGARDING THE VESSEL CHARACTERISTICS. NO ADDITIONAL INFORMATION IS AVAILABLE, AND THE PRODUCTS ARE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROWLER MICROCATHETERS | CES MICROCATHETERS (KRA) | KRA | CORDIS NEUROVASCULAR, INC. | NA | 13470905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | NON-CORDIS COILS |