PRLNE BLU 24IN 6-0 D/A C-1
Report
- Report Number
- 2210968-2022-05104
- Event Type
- Death
- Date Received
- July 5, 2022
- Date of Event
- June 8, 2022
- Report Date
- March 10, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- UDI-DI
- 10705031019805
- PMA / PMN Number
- K133356
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THIS PROCEDURE A CDA: CERVICAL DISC ARTHROPLASTY? NO. WAS THIS PROCEDURE A CEA : CAROTID ENDARTERECTOMY? YES. DID 2 DIFFERENT PATIENTS EXPERIENCE A SUTURE BREAKAGE POST OP? NO, ONE PATIENT. IF THERE IS A 2ND PATIENT, PLEASE PROVIDE THE PC NUMBER FOR THE 2ND PATIENT. IT WAS REPORTED: PROCEDURE DATE: ON (B)(6) 2022, EVENT DATE: 5/31/2022, THE EVENT CANNOT HAPPEN BEFORE THE PROCEDURE. THEREFORE, PLEASE CONFIRM: PROCEDURE DATE: ON (B)(6) 2022, EVENT DATE: 6/8/2022, PROCEDURE DATE IS ON (B)(6) 2022 AND EVENT DATE IS 2022/06/08. WHAT WAS THE DATE OF DEATH? THE DETAIL IS UNKNOWN. WE RECOGNIZE IT WAS ALSO ON (B)(6) 2022. PLEASE PROVIDE THE PATIENT'S WEIGHT AND BMI AT THE TIME OF INDEX PROCEDURE. UNKNOWN. DATE AND NAME OF INDEX SURGICAL PROCEDURE? PROCEDURE DATE: ON (B)(6) 2022, CEA : CAROTID ENDARTERECTOMY. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? UNKNOWN. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? UNKNOWN. ON WHAT TISSUE WAS THE SUTURE USED? INTERNAL CAROTID ARTERY. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HYPERTENSION. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? CONTINUOUS SUTURING. PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. BLEED IN PATIENT'S HOME, SO NO INTERVENTION WAS PERFORMED AND HE PASSED AWAY. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? THE SUTURE WAS BROKEN POST OP. HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? UNKNOWN. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? ON (B)(6) 2022, THE PATIENT BLEED IN HIS HOME. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNKNOWN. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? THE DOCTOR SAID: HE HAD A HISTORY OF HYPERTENSION AND WAS SMOKING, SO HE WAS A HIGH-RISK PATIENT. WILL THE ACTUAL SAMPLE BE RETURNED FOR EVALUATION? NO SAMPLE WILL BE RETUNED. ARE ANY REPRESENTATIVE SAMPLES AVAILABLE FOR EVALUATION? NO SAMPLE WILL BE RETUNED. WAS THERE ANY PRECIPITATING STRESS FACTOR FOR THE SUTURE BREAKAGE? THE PATIENT HAD HYPERTENSION AND HAD A HISTORY OF SMOKING.. HOW WAS SUTURE BREAKAGE CONFIRMED? NO FURTHER INFORMATION IS AVAILABLE. WAS A CAUSE OF DEATH REPORTED WITHIN THE MEDICAL RECORD OR DESCRIBED IN AN AUTOPSY REPORT? IF SO, PLEASE SPECIFY. WE CANNOT GET THE INFORMATION BY NOW. WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? NOW, THEY DON'T NEED SUPPORT OF ETHICON.
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. CORRECTED INFORMATION: G2 IS REPORT SOURCE CONSUMER.
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 RECEIVED: DURING SURGERY, BLEEDING WAS OBSERVED FROM THE INTERNAL CAROTID ARTERY SUTURE SITE. AFTER HEMOSTASIS WAS ACHIEVED WITH ADDITIONAL SUTURING, REINFORCEMENT WAS PERFORMED USING ¿SURGICEL¿ AND FIBRIN GLUE.
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. CORRECTED D3 MANUFACTURER EMAIL. ADDITIONAL G2.
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. 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: "QUANTITY OF BLOOD LOSS? UNKNOWN. PATIENT WEIGHT? UNKNOWN. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. THE PATIENT BLEED AT HOME, SO ANY TREATMENT OR INTERVENTION WAS PERFORMED AND THE PATIENT PASSED AWAY. IF PRODUCT WAS REMOVED, WAS REOPERATION NECESSARY TO REMOVE THE SUTURE AND RE-CLOSE THE WOUND? WHAT IS THE CURRENT STATUS OF THE PATIENT? DEATH. 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 DATE OF DEATH? PLEASE PROVIDE THE PATIENT'S WEIGHT AND BMI AT THE TIME OF INDEX PROCEDURE. DATE AND 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)? 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)? 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 BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? 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? WILL THE ACTUAL SAMPLE BE RETURNED FOR EVALUATION? ARE ANY REPRESENTATIVE SAMPLES AVAILABLE FOR EVALUATION? HOW WAS SUTURE BREAKAGE CONFIRMED? WAS THERE ANY PRECIPITATING STRESS FACTOR FOR THE SUTURE BREAKAGE? CAN YOU SEND THE AUTOPSY REPORT? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.
IT WAS REPORTED THAT A PATIENT UNDERWENT A CDA: CERVICAL DISC ARTHROPLASTY OR A CEA : CAROTID ENDARTERECTOMY AND CONTINUOUS SUTURE WAS USED ON THE INTERNAL DIAMETER ARTERY OR THE CAROTID ARTERY. ON POSTOPERATIVE DAY 8, THE SUTURE BROKE AND HEMORRHAGE OCCURRED AT THE ANASTOMOSIS SITE CAUSED BY BROKEN SUTURE. THE PATIENT DIED BECAUSE THE SUTURE BROKE AND HAEMORRHAGE OCCURRED AT HOME AND TREATMENT COULD NOT BE PERFORMED. THE SURGEON OPINES THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT. THE SURGEON HAD BEEN USING THE PRODUCT FOR A LONG TIME, AND THE SURGEON WAS ABLE TO USE IT WITHOUT ANY PROBLEM. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473244 | PRLNE BLU 24IN 6-0 D/A C-1 | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. | 8726H | PEH130 | 10705031019805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Death| R |