RETRACTA DETACHABLE EMBOLIZATION COIL
Report
- Report Number
- 1820334-2020-00587
- Event Type
- Malfunction
- Date Received
- March 11, 2020
- Date of Event
- March 2, 2020
- Report Date
- June 19, 2020
- Manufacturer
- COOK INC
- Product Code
- KRD
- UDI-DI
- 10827002342023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. D10 ¿ PRODUCT RECEIVED ON: 20MAR2020. INVESTIGATION ¿ EVALUATION. A REPRESENTATIVE FROM MAXIMA MEDISCH CENTRUM INFORMED COOK OF AN INCIDENT INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL. ON 04MAR2020 DURING A PULMONARY VEIN EMBOLIZATION PROCEDURE THE COIL PREMATURELY DEPLOYED. THE COIL BECAME LOOSE AND WAS NOT RETRIEVED. THE COIL REMAINED IN THE TARGETED LOCATION. THE COIL WAS NOT ROTATED WHILE ADVANCED TO THE DELIVERY SITE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY, THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT RETURNED ONE DELIVERY WIRE GUIDE TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED THE WIRE WAS RETURNED USED. THE EMBOLIZATION COIL WAS NOT PRESENT. THE END COIL WAS INTACT. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿THE RETRACTA DETACHABLE EMBOLIZATION COIL IS NOT RECOMMENDED FOR USE WITH POLYURETHANE CATHETERS OR CATHETERS WITH SIDEPORTS. IF A CATHETER WITH SIDEPORTS IS USED, THE EMBOLUS MAY LODGE IN THE SIDEPORT OR PASS INADVERTENTLY THROUGH IT. USE OF A POLYURETHANE CATHETER MAY ALSO RESULT IN LODGING OF THE EMBOLUS WITHIN THE CATHETER.¿ 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 THE COIL DETACHMENT CAN BE EITHER FELT OR VISUALIZED UNDER FLUOROSCOPY.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS SHOWED NO NONCONFORMANCES. A DATABASE SEARCH WAS COMPLETED AND NO ADDITIONAL COMPLAINTS ON THE LOT WERE FOUND. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT. IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THE DEVICE WAS NOT ROTATED WHILE ADVANCING TO THE DELIVERY SITE. THE IFU WARNS THE USER ¿DO NOT TURN THE DELIVERY WIRE COUNTERCLOCKWISE DURING ADVANCEMENT; THE COIL MAY BE UNINTENTIONALLY DETACHED.¿ BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.
ADDITIONAL INFORMATION RECEIVED 08MAY2020: THE OPERATOR REPORTS THAT THEY DID FLUSH THE CATHETER BEFORE COIL DEPLOYMENT, "PER STANDARD PROCEDURE." IT WAS REPORTED THAT THE COIL REMAINED IN THE TARGETED AREA AND "BY PARKING IT ANOTHER COIL, IT CAME LOOSE". THE COIL WAS NOT RETRIEVED AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PMA/510(K) #: K151676. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A PULMONARY VEIN EMBOLIZATION. DURING THE PROCEDURE, THE OPERATOR NOTED THE COIL "CAME LOOSE". 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 |
|---|---|---|---|---|---|---|---|
| 281044 | RETRACTA DETACHABLE EMBOLIZATION COIL | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | 8641055 | 10827002342023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |