MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 36IN 3-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	HS6822H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent coronary artery bypass grafting + mitral valvuloplasty + tricuspid valvuloplasty in hospital on (b)(6) 2024 due to palpitation, chest tightness, shortness of breath and heart failure and suture was used for sewing the superior and inferior vena cava in a continuous suturing manner.Pull off suture needle issue occurred during the surgery.The detached needle was removed from the patient.The surgeon immediately replaced a new suture product to continue the sewing.The subsequent surgery went smoothly.Later, the patient's heart could not rebound, and the surgeon immediately performed rescue.The patient died on (b)(6) 2024.After contacting the hospital, the hospital feedback that the patient had poor heart, poor physical fitness, poor cardiac function and vascular stenosis.The physician considered that the cause of death was patient's physical condition (71-year-old patient with poor cardiopulmonary function), not related to our suture products.According to the information currently available, the cause of this death event could not be confirmed, and the correlation with the suture products was very small according to our local medical affairs team.It was not excluded that the pull off suture needle issue had some influence on the surgical process.Additional information was requested.
Additional Manufacturer Narrative
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.The following information was requested, but unavailable: were the needle pull offs related to the death? did the sutures cause or contribute to the patient's death? if yes, what is the alleged deficiency of the sutures that led to the death? what was the cause of death for the patient? 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.Please provide the patient's weight, bmi at the time of index procedure.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? what instruments were used to grasp the needle/suture? where was the needle grasped during use? 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? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Related medwatch reports: 2210968-2024-03155, 2210968-2024-03156, 2210968-2024-03157, 2210968-2024-03158, 2210968-2024-03159, 2210968-2024-03160.
Additional Manufacturer Narrative
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.Investigation summary: the product was returned to ethicon for evaluation.The returned product determined that it was received, thirteen unopened samples that pertain to the product code hs6822h.This product code is double armed.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.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 Manufacturer Narrative
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: would the surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? no.

• Brand Name: PRLNE HS BLU 36IN 3-0 D/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18927449
• Report Number: 2210968-2024-03155
• Device Sequence Number: 17255643
• Product Code: GAW
• UDI-Device Identifier: 10705031232754
• UDI-Public: 10705031232754
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: HS6822H
• Device Lot Number: RCBJBD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 04/08/2024; 05/05/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/18/2024; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 71 YR
• Patient Sex: Male