MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
Report
- Report Number
- 3002808486-2017-01343
- Event Type
- Injury
- Date Received
- June 26, 2017
- Date of Event
- June 2, 2017
- Report Date
- June 2, 2017
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- KRD
- UDI-DI
- 00827002202344
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K): K063619. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4) G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: EVENT DESCRIPTION STATES THAT THE COIL DETACHED FROM THE DELIVERY WIRE WHEN THE DEVICE REACHED THE RIGHT ATRIUM. WHY, AND HOW, THE DEVICE REACHED THE RIGHT ATRIUM IS UNKNOWN, BUT SINCE FEMORAL ARTERY WAS THE ENTRY POINT (AS INSTRUCTED BY IFU) IT MUST IMPLY THAT THE DEVICE PASSED THE TARGET SITE, THE PATENT DUCTUS ARTERIOSUS, AND WAS ADVANCED A RELATIVELY LONG DISTANCE FURTHER ON THROUGH COMPLICATED ANATOMY. IT IS NOT KNOWN WHETHER THE COIL WAS INSIDE THE CATHETER WHEN REACHING THE RIGHT ATRIUM, BUT SINCE IT DETACHED AND WENT LOOSE IN THE HEART THE COIL IS PRESUMED TO HAVE BEEN OUTSIDE THE CATHETER. THIS WOULD BE UNEXPECTED IF DEVICE WAS IN RIGHT ATRIUM, WHICH IS NOT THE TARGET SITE. IT COULD INDICATE THAT THE PROCEDURE DID NOT PROCEED AS STANDARD AND THAT PERHAPS MORE TWISTING OF PRODUCT OCCURRED THAN IT IS DESIGNED FOR. NO FURTHER INFORMATION IS AVAILABLE FOR THIS COMPLAINT, SO UNABLE TO INVESTIGATE FURTHER. THE INSTRUCTIONS FOR USE (IFU) DESCRIBES HOW TO LOAD THE COIL ON DELIVERY WIRE. TO ADDRESS THE ISSUE OF UNINTENTIONAL COIL DETACHMENT, THE IFU INSTRUCTS THE USER TO NOT ROTATE THE DELIVERY WIRE COUNTERCLOCKWISE DURING INSERTION; ROTATION MIGHT DETACH THE COIL INADVERTENTLY. THE IFU ALSO INSTRUCTS THE USER TO NOT ATTEMPT TO WITHDRAW THE DELIVERY WIRE, BUT INSTEAD REMOVE THE GUIDING CATHETER AND THE DELIVERY WIRE WITH THE COIL. THE IFU CONTAINS THE ADDITIONAL INFORMATION THAT IN CASE OF MISPLACEMENT OR INADVERTENT DETACHMENT OF A COIL, THE COOK VASCULAR RETRIEVAL FORCEPS CAN BE USED FOR RETRIEVAL OF THE COIL THROUGH THE SHEATH. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER ADVANCED THE DEVICE THROUGH FEMORAL ARTERY. THEN THEY FOUND THE COIL DROPPED OFF IN ADVANCE WHEN THE DEVICE REACHED RIGHT ATRIUM. THEY COULD NOT PROVIDE ANY IMAGE OR PICTURES ABOUT OPERATING PROCEDURE. USED LOCAL BRAND RETRIEVAL SET TO ADVANCE THROUGH FEMORAL ARTERY AND FETCH THE COIL OF PATIENT BODY. NO SECTION WAS LEFT INSIDE PATIENT BODY. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448924 | MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | WILLIAM COOK EUROPE | 00827002202344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Life Threatening |