RETRACTA DETACHABLE EMBOLIZATION COIL
Report
- Report Number
- 1820334-2022-01782
- Event Type
- Malfunction
- Date Received
- November 29, 2022
- Date of Event
- November 15, 2022
- Report Date
- March 9, 2023
- Manufacturer
- COOK INC
- Product Code
- KRD
- PMA / PMN Number
- K151676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. A REPRESENTATIVE OF PRESBYTERIAN HEALTH SERVICE CORP (UNITED STATES) INFORMED COOK ON 21NOV2022 OF AN EVENT THAT OCCURRED ON 15NOV2022 INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL (RPN: MWCER-35-14-12; LOT: 9992231). A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN EMBOLIZATION PROCEDURE. PER THE PHYSICIAN, THE PROXIMAL PART OF THE DELIVERY WIRE SEPARATED IN THE CATHETER WHILE RETRACTING THE COIL DURING THE PROCEDURE. THE COIL DETACHED AND REMAINED IN PLACE. THE REMAINING WIRE WAS PINNED AND SCREWED WITH A DETACHMENT PART IN THE CATHETER WITH A NON-COOK PRODUCT WIRE. ALL PARTS OF THE DEVICE WERE REMOVED AND ACCESS SITE WAS RELINQUISHED. A NEW DEVICE WAS USED TO REGAIN ACCESS AND COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED ONE USED DEVICE FOR EVALUATION. UPON VISUAL INSPECTION, THE WIRE WAS LODGED INSIDE THE CATHETER. THE DISTAL END OF THE WIRE WAS OBSERVED TO BE STRETCHED, ELONGATED, AND EXITING FROM THE DISTAL TIP OF THE CATHETER. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT 9992231 REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU [T_MWCER_REV4] PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE INFORMATION PROVIDED UPON REVIEW OF THE DEVICE MASTER RECORD, INSTRUCTIONS FOR USE, AND DEVICE HISTORY RECORD, DOES NOT INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. IT WAS DISCOVERED DURING DEVICE EVALUATION THAT THE DELIVERY WIRE WAS STRETCHED AND ELONGATED, AS WELL AS LODGED IN THE CATHETER; HOWEVER, THE WIRE WAS NOT SEPARATED. THE CUSTOMER STATED THAT THE CATHETER WAS FLUSHED AS DIRECTED PER THE IFU, AND THE CATHETER USED WAS OF THE RECOMMENDED SIZE. THEREFORE, COOK DOES NOT SUSPECT USER ERROR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INITIAL REPORTER OCCUPATION: SUPERVISOR. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IN ADDITIONAL INFORMATION, IT WAS REPORTED THE ANATOMICAL TARGET DURING THE EMBOLIZATION PROCEDURE WAS A 7-8 MM LEFT OVARIAN VEIN. A 5 FRENCH CATHETER WAS FLUSHED PRIOR TO EACH COIL DEPLOYMENT. THE COIL JUNCTION WAS WITHIN THE TIP OF THE CATHETER DURING DEPLOYMENT, AND THE TORQUE DEVICE WAS UTILIZED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED, WHILE PLACING A RETRACTA DETACHABLE EMBOLIZATION COIL THE DELIVERY WIRE SEPARATED IN A PATIENT. A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN EMBOLIZATION PROCEDURE. PER THE PHYSICIAN, THE PROXIMAL PART OF THE DELIVERY WIRE SEPARATED IN THE CATHETER WHILE RETRACTING THE COIL DURING THE PROCEDURE. THE COIL DETACHED AND REMAINED IN PLACE. THE REMAINING WIRE WAS PINNED AND SCREWED WITH A DETACHMENT PART IN THE CATHETER WITH A NON-COOK PRODUCT WIRE. ALL PARTS OF THE DEVICE WERE REMOVED AND ACCESS SITE WAS RELINQUISHED. A NEW DEVICE WAS USED TO REGAIN ACCESS AND COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2083318 | RETRACTA DETACHABLE EMBOLIZATION COIL | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | 9992231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | AMPLATZ WIRE, MANUFACTURER UNKNOWN.| AZUR COIL X2- REF:(B)(4), LOT# 2101295J2.| AZUR COIL- REF: (B)(4), LOT#2103165J2.| AZUR DETACH CONTROL- (B)(4), LOT# 0000123254.| CATHETER- COOK 5FR BEACON TIP C2 038.| COOK COIL X2: MWCER-35-14-10.| COOK COIL X4: MWCER-35-14-12. |