PRLNE BLU 36IN 4-0 D/A SH
Report
- Report Number
- 2210968-2024-08062
- Event Type
- Death
- Date Received
- August 7, 2024
- Date of Event
- July 16, 2024
- Report Date
- October 28, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- UDI-DI
- 10705031016538
- PMA / PMN Number
- K133356
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- 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: PLEASE CONFIRM: IS LOT UABHBS THE LOT NUMBER USED DURING THIS CARDIAC PROCEDURE? REGARDING LOT NUMBER UABHBS. UABHBS COULD NOT BE CONFIRMED. OTHER POTENTIAL LOT NUMBERS ARE TMBBQZ AND TMBCEM. THESE WERE OPEN BOXES THE SUTURE IN QUESTION COULD HAVE ORIGINATED FROM. ALL LOT NUMBERS HAVE BEEN SEQUESTERED AND WILL BE RETURNED TO ETHICON. ACCOUNT REFUSES TO USE ANY REMAINING SUTURE FROM THESE LOT NUMBERS AND REQUESTS REPLACEMENTS WITH DIFFERENT LOT. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING POSSIBLE BATCH NUMBERS WERE REPORTED: BATCH UABHBS, MFG DATE: 01/24/2024, EXP DATE: 12/31/2028. BATCH TMBBQZ, MFG DATE: 11/07/2023, EXP DATE: 10/31/2028. BATCH TMBCEM, MFG DATE: 11/09/2023, EXP DATE: 10/31/2028. IN ADDITION, A REVIEW OF THE MANUFACTURING RECORD EVALUATIONS FOR THE POSSIBLE BATCH NUMBERS WERE PERFORMED FOR THE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. WERE 2 SUTURES USED DURING THE INITIAL PROCEDURE? WHAT WAS THE DEFICIENCY WITH THE SUTURE? PLEASE DESCRIBE. DID 2 SUTURE BREAK POST-OP? IF YES, WHERE WAS THE BREAK ON THE SUTURE NOTED? OR DID 2 SUTURES PULL OUT OF THE TISSUE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? WHAT INSTRUMENTS WERE USED IN THIS PROCEDURE TO HANDLE THE SUTURE? ON WHAT TISSUE WAS THE SUTURE USED/LOCATION OF SUTURE PLACEMENT FOR EACH SUTURE? WHAT TISSUE DEHISCED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? HOW WAS THE DEHISCENCE MANAGED? WHAT WAS THE SOURCE AND TRIGGERING EVENT OF BLEEDING? WHAT WAS THE VOLUME OF BLOOD LOSS? HOW WAS THE BLEEDING TREATED? WAS ANY MEDICAL/SURGICAL INTERVENTION PERFORMED POST-OP WHEN THE INCISION RE-OPENED TO TRY AND STOP THE BLEEDING? IF YES, PLEASE DESCRIBE. WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF THE INCISION REOPENING AND BLEEDING? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE? IF SO, CAN THE RESULTS BE SHARED? WOULD THE PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.
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 INFORMATION: H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING POSSIBLE BATCH NUMBERS WERE REPORTED: BATCH UABHBS MFG DATE: 01/24/2024, EXP DATE: 12/31/2028. BATCH TMBBQZ MFG DATE: 11/07/2023, EXP DATE: 10/31/2028. BATCH TMBCEM MFG DATE: 11/09/2023, EXP DATE: 10/31/2028. BATCH TJBKPL MFG DATE: 8/29/2023, EXP DATE 7/31/2028. IN ADDITION, A REVIEW OF THE MANUFACTURING RECORD EVALUATIONS FOR THE POSSIBLE BATCH NUMBERS WERE PERFORMED FOR THE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. TWO REPRESENTATIVE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE 8521H, LOT TJBKPL. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKETS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO THE CUSTOMER COMPLAINT AND NO DEFECTS WERE OBSERVED DURING EVALUATION. THE FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. TEN REPRESENTATIVE UNOPENED SAMPLES, SIX UNUSED OPEN SAMPLES AND TWO EMPTY LABELED WINDING FORMERS WERE RECEIVED FOR ANALYSIS. PRODUCT CODE 8521H, LOT UABHBS. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKETS. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES AND THE SIX OPENED SAMPLES, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO THE CUSTOMER COMPLAINT AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.
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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? MITRAL STENOSIS AND INSUFFICIENCY WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? OPEN WHAT INSTRUMENTS WERE USED IN THIS PROCEDURE TO HANDLE THE SUTURE? CASTRO NEEDLE DRIVER ON WHAT TISSUE WAS THE SUTURE USED/LOCATION OF SUTURE PLACEMENT FOR EACH SUTURE? LEFT ATRIUM WHAT TISSUE DEHISCED? LEFT ATRIUM WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? NORMAL HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? CONTINUOUS HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? 5 KNOTS HOW WAS THE DEHISCENCE MANAGED? PATIENT WAS OPENED EMERGENTLY AT THE BEDSIDE IN THE POSTOP ICU WHAT WAS THE SOURCE AND TRIGGERING EVENT OF BLEEDING? UNKNOWN. SUTURE WAS FOUND BROKEN WHAT WAS THE VOLUME OF BLOOD LOSS? MASSIVE 6+L HOW WAS THE BLEEDING TREATED? OPENED THE PATIENT AND BLOOD GIVEN WAS ANY MEDICAL/SURGICAL INTERVENTION PERFORMED POST-OP WHEN THE INCISION RE-OPENED TO TRY AND STOP THE BLEEDING? IF YES, PLEASE DESCRIBE. ALL THE BLOOD HAD EXITED THE PATIENT. THIS WAS A MASSIVE BLOOD LOSS WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF THE INCISION REOPENING AND BLEEDING? NO DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? NOT IN THIS CASE OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NONE WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?SUTURE FRACTURE HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASE? IF SO, CAN THE RESULTS BE SHARED? AUTOPSY NOT NEEDED SINCE WE OPENED THE PATIENT WOULD THE PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? YES.
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 INFORMATION: H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM. ADDITIONAL H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. FOUR REPRESENTATIVE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE 8521H, LOT TMBCEM. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKETS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO THE CUSTOMER COMPLAINT AND NO DEFECTS WERE OBSERVED DURING EVALUATION. THE FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. SIXTEEN REPRESENTATIVE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE 8521H, LOT TMBBQZ. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKETS. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES, THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED TO THE CUSTOMER COMPLAINT AND NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 AN ELECTIVE CARDIAC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED TO CLOSE THE INCISION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SIX HOURS POST-OP, THE PATIENT¿S INCISION REOPENED AND THE PATIENT EXSANGUINATED INSTANTANEOUSLY, RESULTING IN IMMEDIATE PATIENT DEATH. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 534569 | PRLNE BLU 36IN 4-0 D/A SH | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. | 10705031016538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| D |