MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A BV-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8702H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg procedure on (b)(6) 2024 and suture was used.It was reported that the cv surgeon experienced suture detached from swage when he is performing distal anastomosis during cabg procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/7/2024.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr.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, or its employees that the report constitutes an admission that the product, ethicon, 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.A manufacturing record evaluation was performed for the finished device lot, 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: was there any change in the patient¿s post-operative care due to the prolonged procedure? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).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 Manufacturer Narrative
Product complaint #(b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please confirm the quantity of devices involved in the reported event.Ans: 1.Please confirm the quantity of devices available for product return.Ans: as confirmed by sales rep via msteams on 07 oct 2024, the complaint device is no longer available for return.Please change the qty to 0.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).Ans: sales rep.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Ans: n/a.No product is available for return.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, or its employees that the report constitutes an admission that the product, ethicon, 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 Manufacturer Narrative
(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: c22 - photo analysis h6 component code: g07002 no device returned.Additional information: h6, h3 photo review: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a winding former labeled as ep8702 with body fluids, two needles with an apparent detachment of one of the needles.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be 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.H3 investigation summary: the product was returned to ethicon for evaluation.One winding formed with one detached needle and a needle suture piece was received for analysis.The product code ep8702h is double-armed.A photo was provided, and it showed a plastic bag with a winding former with a detached needle and needle suture for product code ep8702.Upon visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was found.In addition, the needle suture piece was visually inspected, and the swage and attachment area were noted to be as expected.The suture was examined and the end of the suture was noted to be cut probably caused by a surgical instrument.In addition, the other section of the suture was not returned for evaluation to determine the assignable cause.The functional test was performed using an instron equipment and tensile force was above the minimum requirements.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Per the conditions of the returned sample, no conclusion could be reached on the cause of the reported event as part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PRLNE BLU 24IN 7-0 D/A BV-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 20385773
• Report Number: 2210968-2024-10571
• Device Sequence Number: 15463176
• Product Code: GAW
• UDI-Device Identifier: 10705031206793
• UDI-Public: (01)10705031206793(17)281031(10)TMBBLX
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/17/2025

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: EP8702H
• Device Lot Number: TMBBLX
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 11/12/2024; 12/23/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/30/2024; 12/09/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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