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

Catalog Number	EP8704H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 5/9/2025.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.Additional information was requested, the following was obtained: ¿ were there patient consequences? if yes, please explain.There is no direct negative impact on the patient however, the procedure took longer than expected, and the sutures utilization were higher than necessary because of the needle detachment.¿ please confirm if the device is available for product analysis.If yes, kindly provide us with the shipping status and shipment tracking details yes, we have collected one sample for analysis.¿ what is meant by ¿the sutures utilization were higher than necessary¿.Did more than 1 suture pull off during the procedure? if yes, please provide the quantity of sutures that pulled off.The number of detachments vary from 2-4 detachments per case.¿ was the patient treatment or post-operative care altered in any way due to the prolonged surgery time? if yes, please explain.No direct impact on the patients¿ health.¿ was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? no.¿ what is the patient¿s current status? good.¿ status of the device being returned? two samples of the detached needle and thread have been returned, and according to the website, the samples have been delivered.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.
Event or Problem Description
It was reported that a patient underwent a cabg procedure on an unknown date and suture was used.During the procedure, needle-thread detachment occurred while making the anastomosis.There were no adverse patient consequences, however, the procedure took longer than expected, and the sutures utilization were higher than necessary because of the needle detachment.Additional information was requested.

• Brand Name: PRLNE BLU 24IN 7-0 D/A CC 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21994157
• Report Number: 2210968-2025-05133
• Device Sequence Number: 14574700
• Product Code: GAW
• UDI-Device Identifier: 10705031206779
• UDI-Public: (01)10705031206779(17)290731(10)10300Z
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: EP8704H
• Device Lot Number: 10300Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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