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

Catalog Number	8703H
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cv cabg surgery on (b)(6) 2026 and suture was used.During the procedure, when closing the distal anastomosis, the suture broke, pulled apart, fell apart and disintegrated.It happened in different places on each suture, not where the needle and suture meet that stayed intact and it was not extra tension on the suture.The patient showed bleeding on those anastomosis spots and hemostasis products were used on top of each suture.Another like device was used to finish the case.
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.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.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.For the intra-op event of multiple 7-0 prolene sutures ¿broke, pulled apart, fell apart and disintegrated¿.Please confirm the quantity for each lot number.Lot 107ph0 ¿ 3 devices.Is this correct? if this is not correct, please clarify.Lot 104mdg ¿ 1 device.Is this current? if this is not correct, please clarify.The initial event information stated the patient required extended hospitalization as a result of the event - patient had extra bleeding that needed to be monitored please clarify: is the extra bleeding that had to be monitored refer the bleeding experienced intra-op where additional sutures were required or the post-op bleeding? what were the results of monitoring the bleeding? was any additional intervention required for the bleeding? for example, a blood transfusion.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? were sleeves or bolsters used on instruments to handle the sutures? what was the volume of blood loss that occurred during the initial procedure? what was the volume of blood loss that occurred post-op? when did the bleeding occur post-op (numbers of hours/days)? what was the bleeding source and triggering event? was there any suture deficiency with the suture that was in place when the post-op bleeding occurred? how was the bleeding treated? 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? was the patient on anti-coagulants prior to surgery? 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? will any actual samples or representative samples be returned? if so, please provide the return date and tracking information.Additional information: other products utilized during the case but did not contribute to the reported event: surgicel powder, vistaseal, surgiflo, vicryl suture.
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: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: our failure analysis lab received an extra product with reference to this complaint, it was received: product code: 8706h.Product lot/batch: 109rms.1.Could you please clarify if extra device belongs to this complaint? 2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Response received: the issue was on all the 7-0 sutures.They only gave me the empty packages of the sutures.The other sutures were used but the hospital put all them in the bag.The 7-0 that was not opened was not used but put into the bag.I send what the hospital gave me.Additional h6 component code: g07002 no device problem additional h3 investigation summary: the product was returned to eth for evaluation.Two representative unopened samples were received for analysis.Product code 8703h.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions 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 strands to detect any issue related to fraying or damaged suture and no defects were observed during evaluation.Also, a tactile test was performed with the affected parts of the thumb and forefinger, and no anomalies were detected.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.The event described could not be confirmed as 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.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25055664
• Report Number: 2210968-2026-04732
• Device Sequence Number: 10062588
• Product Code: GAW
• UDI-Device Identifier: 10705031019348
• UDI-Public: (01)10705031019348(17)300331(10)107PH0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8703H
• Device Lot Number: 107PH0
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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
• Patient Sex: Unknown