RETRACTA DETACHABLE EMBOLIZATION COIL
Report
- Report Number
- 1820334-2022-01778
- Event Type
- Malfunction
- Date Received
- November 29, 2022
- Report Date
- February 16, 2023
- Manufacturer
- COOK INC
- Product Code
- KRD
- PMA / PMN Number
- K151676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION AN OBSERVATIONAL POST-MARKET STUDY COMPLAINT WAS RECEIVED ON 18NOV2022 STATING THAT THERE WAS AN ISSUE WITH A RETRACTA DETACHABLE EMBOLIZATION COIL (RPN: MWCER-35-14-10; UNKNOWN LOT) THAT WAS DIFFICULT TO ADVANCE. AFTER REVIEWING THE SALES HISTORY FOR THIS CUSTOMER, THREE POSSIBLE LOT NUMBERS (7947741, 9243993, 9200772) WERE IDENTIFIED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES FOR THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). AFTER REVIEWING THE SALES HISTORY FOR THIS CUSTOMER, THREE POSSIBLE LOT NUMBERS (7947741, 9243993, 9200772) WERE IDENTIFIED. OF THESE POSSIBLE LOT NUMBERS, THERE WERE NO RELATED NONCONFORMANCES, AND A DATABASE SEARCH FOR COMPLAINTS ON THE POSSIBLE LOTS FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [T_MWCER_REV6] STATE THE FOLLOWING: "PRECAUTIONS PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, FLUSH THE ANGIOGRAPHIC CATHETER WITH SALINE. INSTRUCTIONS FOR USE 6. UNDER FLUOROSCOPIC VISUALIZATION, SLOWLY ADVANCE THE DELIVERY WIRE UNTIL THE ENTIRE LENGTH OF THE COIL EXITS THE DISTAL END OF THE CATHETER. ENSURE THAT THE JUNCTION REMAINS POSITIONED JUST INSIDE THE CATHETER TIP. NOTE: ADVANCING THE DELIVERY WIRE SLOWLY ALLOWS THE JUNCTION TO BE SEEN MORE EASILY AND REDUCES THE RISK OF DAMAGING IT. NOTE: IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING COIL ADVANCEMENT. DO NOT CONTINUE ADVANCING. RETRACT THE DELIVERY WIRE SLIGHTLY, THEN GENTLY RE-ADVANCE IT. IF THERE IS STILL SIGNIFICANT RESISTANCE, WITHDRAW THE DELIVERY WIRE FROM THE CATHETER AND TRY USING A NEW COIL WITH A SHORTER LENGTH. NOTE: DO NOT TURN THE DELIVERY WIRE COUNTERCLOCKWISE DURING ADVANCEMENT; THE COIL MAY BE UNINTENTIONALLY DETACHED. 8. IF THE COIL POSITION IS CORRECT, USE THE TORQUE DEVICE TO TURN THE DELIVERY WIRE COUNTERCLOCKWISE 8-10 TIMES, UNTIL COIL DETACHMENT CAN BE EITHER FELT OR VISUALIZED UNDER FLUOROSCOPY. NOTE: IT IS RECOMMENDED THAT THE JUNCTION REMAIN JUST INSIDE THE TIP OF THE CATHETER. NOTE: DO NOT ADVANCE THE DELIVERY WIRE AFTER THE COIL IS DETACHED. THE INFORMATION PROVIDED UPON REVIEW OF THE DEVICE MASTER RECORD, DEVICE HISTORY RECORD, AND INSTRUCTIONS FOR USE, 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, NO 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 IS POSSIBLE THAT THE CATHETER WAS NOT PROPERLY FLUSHED PRIOR TO DEPLOYMENT, OR THE DELIVERY WIRE WAS TURNED THE WRONG DIRECTION, BUT THIS CANNOT BE DEFINITIVELY CONFIRMED. 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.
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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED THAT A COOK RETRACTA DETACHABLE EMBOLIZATION COIL WAS NOT ABLE TO BE SUCCESSFULLY DEPLOYED DURING A DEVASCULARIZATION OF BENIGN OR NON-NEOPLASTIC TISSUE PROCEDURE IN (B)(6) 2020. THE BENIGN OR NON-NEOPLASTIC TISSUE WAS CAUSING THE PATIENT TO SUFFER FROM PELVIC CONGESTION SYNDROME. THE EMBOLIZATION TARGET VESSEL WAS THE PELVIC/OVARIAN VEIN. DURING THE PROCEDURE, 10 OTHER COILS WERE DEPLOYED AND 3 ML OF SCLEROSANT WAS USED. THE COOK RETRACTA DETACHABLE EMBOLIZATION COIL DID NOT DEPLOY DURING THE PROCEDURE; IT WAS REPORTED TO HAVE BEEN "STUCK." THE COIL WAS DISLODGED SUCCESSFULLY WITH THE AID OF A CONSULTANT COLLEAGUE. IT WAS NOTED THAT THE RIGHT OVARIAN VEIN NOT SUCCESSFULLY ACCESSED LEADING TO SIGNIFICANT REFLUX IN THE RIGHT SIDE OF THE PELVIS, CONNECTING TO HER RIGHT LABIAL VARIX. A PROCEDURE WAS COMPLETED TO EMBOLIZE THE RIGHT OVARIAN VEIN ON (B)(6) 2020. THE PATIENT RECOVERED AND STABILIZED 98 DAYS AFTER THE INITIAL PROCEDURE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1947459 | RETRACTA DETACHABLE EMBOLIZATION COIL | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | 1 COOK NESTER (RPN UNKNOWN)| 10 COILS (MANUFACTURER UNKNOWN)| FIBROVEIN 3% |