MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8558H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a light upper lobe sleeve lobectomy on an unknown date and suture was used for bronchial anastomosis.There was a suspected suture failure at the anastomosis.Emergency surgery was performed and right pneumonectomy was performed.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned 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.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.The file was created with product code of 8558h for prolene 3-0.The event description states prolene 4-0.Please confirm: what is the product code and lot number? was the device used a prolene 3-0 or 4-0? please provide translation of event description (local language) was emergency surgery of a right pneumonectomy performed? please provide the patient's demographic information including weight, bmi at the time of index procedure date 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 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.)? please describe what is meant by suture failure? why was it suspected that there was a suture failure at the anastomosis? was the suspicion of a suture failure noticed intra-op during the initial procedure or post-op? please explain.What symptoms did the patient experience following the index surgical procedure? onset date? please describe any medical/surgical intervention required for this suture event including dates and results.Please describe the appearance of the suture during re-operation, if applicable.Did the suture break post-op? 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? what is the patient's current status? surgeon¿s name?.
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.Corrected information: d1, d4 catalog, h6.Additional information was requested, and the following was obtained: the file was created with product code of 8558h for prolene 3-0.The event description states prolene 4-0.Please confirm: what is the product code and lot number? unk.Was the device used a prolene 3-0 or 4-0? 4-0.Was emergency surgery of a right pneumonectomy performed? yes.Please provide the patient's demographic information including weight, bmi at the time of index procedure: unk.Date of index surgical procedure? unk.The diagnosis and indication for the index surgical procedure? unk.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? unk.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unk.How was the suture placed (interrupted or continuous)? unk.How was the suture originally tied (multiple knots, square knot, etc.)? unk.Please describe what is meant by suture failure? anastomotic failure.Why was it suspected that there was a suture failure at the anastomosis? unk.What symptoms did the patient experience following the index surgical procedure? onset date? unk.Please describe any medical/surgical intervention required for this suture event including dates and results.Emergency reoperation.Please describe the appearance of the suture during re-operation, if applicable.Unk.Did the suture break post-op? unk.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unk.Other relevant patient history/concomitant medications? unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event?unk.What is the patient's current status? unk.Surgeon¿s name? unk.This was a case presented at a doctor's presentation, and no further details were available.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21233297
• Report Number: 2210968-2025-00950
• Device Sequence Number: 8537927
• Product Code: GAW
• UDI-Device Identifier: 10705031017092
• UDI-Public: 10705031017092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8558H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown