PRLNE BLU 24IN 7-0 D/A BV-1
Report
- Report Number
- 2210968-2024-13399
- Event Type
- Death
- Date Received
- December 12, 2024
- Date of Event
- December 2, 2024
- Report Date
- January 9, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- UDI-DI
- 10705031019324
- PMA / PMN Number
- K133356
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. PLEASE CONFIRM THE TOTAL QUANTITY OF DEVICE INVOLVED IN THIS COMPLAINT IS 3 OR 4. AS THE NEWLY OPENED SUTURE (TIE USING BASIC HAND TYING) SNAPPED AFTER THE 3RD SUTURE SNAPPING ACCORDING TO THE EVENT DESCRIPTION. ANS: 3RD SUTURE SNAPPED DURING THE ANASTOMOSES, SURGEON RETRIED DOING THE ANASTOMOSES 3 TIMES AND SUTURE DID NOT SNAP ON THE 4TH TRIAL. SURGICAL ASSISTANCE OPENED UP A NEW PACK OF PROLENE 7/0 FROM THE SAME PACKAGING AND TRIED TYING THE NEW SUTURE ON THE TABLE TO TEST ON THE TENSILE STRENGTH AND HE COMPLAINED THAT IS WAS NOT AS PER USUAL, JUST WITH A SLIGHT EXTRA TENSION THE SUTURE SNAPPED. SURGEON AND NURSES COULD NOT INFORM SALES REP ON THE EXACT BATCH AS IT WAS AM EMERGENCY SITUATION THAT THEY WERE FOCUSING ON MANAGING. HOWEVER, THESE 2 BATCHES OF PROLENE 7/0 REPORTED WERE PRESENT IN THE OT DURING THE CASE. 2. IS THE SAPHENOUS VEIN GRAFT INDEED TRAUMATIZED AFTER REDOING THE ANASTOMOSES? ANS: YES, THE SVG WAS TRAUMATIZED AS SURGEON HAD TO DO 3 ANASTOMOSES ON THE SAME SPOT DUE TO THE SUTURE SNAPPING AFTER ANASTOMOSES DURING KNOT TYING. 3. IF YES, COULD YOU PLEASE CLARIFY WHETHER THERE WERE ANY PATIENT CONSEQUENCES (E.G., PATIENT HARM) RESULTING FROM THE TRAUMATIZED SAPHENOUS VEIN GRAFT? ANS: (RESPONSE PROVIDED AT (B)(6)2024 9:11 AM) - PATIENT CONSEQUENCES UNKNOWN AS SURGERY WAS ONGOING FOR MORE THAN 12 HOURS PARTIALLY DUE TO THIS ISSUE. WILL RECONFIRM WITH SURGEON ON THE PATIENT STATUS SOON. SURGEON OUT LOOK ON PATIENT? S CONDITION WAS NOT GOOD. (RESPONSE PROVIDED AT (B)(6)2024 1:53 PM) - SURGEON INFORMED TODAY THAT PATIENT HAS PASSED AWAY LAST NIGHT. SALES REP WILL NEED TO MEET FACE TO FACE WITH THE SURGEON TO GET MORE INFORMATION ON THE SUSPECTED CAUSE AS THIS INFORMATION IS P&C. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE CAUSE OF DEATH? WHAT INSTRUMENTS WERE USED IN THIS PROCEDURE TO HANDLE THE SUTURE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE OF INDEX SURGICAL PROCEDURE? CONFIRM DATE OF DEATH WAS (B)(6)2024. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? WAS THE INITIAL PROCEDURE COMPLETED SUCCESSFULLY? WAS THERE A SUTURE ISSUE THAT CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH? IF YES, PLEASE EXPLAIN. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY WITH THE 4TH SUTURE THAT WAS USED TO COMPLETE THE PROCEDURE? (BEFORE, DURING, AFTER SUTURE PLACEMENT OR DURING ANY RE-OPERATION) WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT?
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL H6 TYPE OF INVESTIGATION: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. WHAT WAS THE CAUSE OF DEATH? ANS: HCP DID NOT SPECIFY. 2. WHAT INSTRUMENTS WERE USED IN THIS PROCEDURE TO HANDLE THE SUTURE? ANS: TCRAT MICRO NEEDLE HOLDER FOR 7/0 PROLENE. 3. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. ANS: NOT INFORMED, WILL GET MORE INFO FROM HCP IF REQUIRED. 4. DATE OF INDEX SURGICAL PROCEDURE? ANS: (B)(6) 2024. 5. CONFIRM DATE OF DEATH WAS (B)(6) 2024. ANS: YES. 6. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ANS: UNKNOWN. 7. ON WHAT TISSUE WAS THE SUTURE USED? ANS: CORONARY ARTERY AND SAPHENOUS VEIN GRAFT. 8. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? ANS: CALCIFIED AND FRAGILE. 9. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? ANS: CONTINUOUS. 10. HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? ANS: MUTLIPLE KNOTS. 11. WAS THE INITIAL PROCEDURE COMPLETED SUCCESSFULLY? ANS: YES. 12. WAS THERE A SUTURE ISSUE THAT CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH? IF YES, PLEASE EXPLAIN. ANS: UNKNOWN, HOWEVER THE SNAPPING ISSUE WHILE SUTURING LEAD TO A DELAY IN THE SURGICAL PROCEDURE AS SURGEON HAD TO REDO THE WHOLE ANASTOMOSES AS SURGEON WAS UNABLE TO COMPLETE THE ANASTOMOSES RING OF THE CORONARY TO GRAFT ANASTOMOSES. 13. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. ANS: SALES REP REQUESTED TO ELABORATE ON THIS QUESTION. 14. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY WITH THE 4TH SUTURE THAT WAS USED TO COMPLETE THE PROCEDURE? (BEFORE, DURING, AFTER SUTURE PLACEMENT OR DURING ANY RE-OPERATION). ANS: NO NOTED ANOMALY WAS DETECTED WITH THE 4TH SUTURE. 15. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? ANS: NOT INFORMED, WILL GET MORE INFO FROM HCP IF REQUIRED. 16. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? ANS: NOT INFORMED, WILL GET MORE INFO FROM HCP IF REQUIRED. 17. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? ANS: NOT INFORMED, WILL GET MORE INFO FROM HCP IF REQUIRED. 18. WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? ANS: YES, IT WOULD BE POSSIBLE TO ARRANGE IF REQUIRED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY. WHAT HAPPENED AFTER THE SUCCESSFUL PROCEDURE THAT LED TO THE PATIENT¿S DEATH, 5 DAYS POST OP? TO CLARIFY QUESTION ¿13. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. ANS: SALES REP REQUESTED TO ELABORATE ON THIS QUESTION.¿ WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED IN ADDITION TO RE-SUTURING OF THE ANASTOMOSIS SITE?
PRODUCT COMPLAINT # ==>(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND ADDITIONAL INFORMATION: D9, H3, H6 INVESTIGATION SUMMARY ==> THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THREE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE 8702H. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO ISSUES RELATED TO BREAKAGE SUTURES OR ANOMALIES WERE OBSERVED DURING THE EVALUATION. ALSO, A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.
IT WAS REPORTED THAT A PATIENT UNDERWENT A TCRAT MIS CABG PROCEDURE AND SUTURE WAS USED. THE SUTURE SNAPPED DURING PROXIMAL ANASTOMOSES WITH THE KNOT PUSHER EVEN WITH A STATIC KNOT PUSHER. CUSTOMER OPENED A NEW SUTURE PACK. SURGEON HAD TO REDO THE ANASTOMOSES WHICH IN RETURN WILL TRAUMATIZE THE SAPHENOUS VEIN GRAFT USED IN CABG. THE PATIENT PASSED AWAY ON (B)(6)2024. ADDITIONAL INFORAMTION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2410300 | PRLNE BLU 24IN 7-0 D/A BV-1 | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. | SHBBKT | 10705031019324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| D |