MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number EP8735H

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an abdominal aortic aneurysm repair surgery on (b)(6) 2024 and suture was used.The needle broke off from the thread during surgery.The needle almost went inside the patient.Surgery was delayed by 30 minutes due to the event, and was successfully completed.Fragments were easily removed without additional intervention.Additional information was requested.

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.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.It was reported that needle almost went inside the patient and there was patient consequences.Did the needle fall into the patient? if yes, was the needle retrieved during the same procedure? were x-rays taken to locate the needle? what measures were taken to retrieve the needle? was there any additional tissue damage as a result of searching for the needle? does a piece of the needle remain in the patient¿s tissue? if yes, is there any plan in place to remove the needle in the future? if yes, please provide the scheduled date.What tissue structure the needle was located? what is the surgeon's opinion of consequences to the patient? were there any unexpected outcomes or complications as a result of the prolonged surgery time? what tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? attempts are being 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.H6 component code: g07002 ¿ device not returned related events captured via: 2210968-2024-03419, 2210968-2024-03420, 2210968-2024-03421, 2210968-2024-03422.

• Brand Name: PRLNE BLU 24IN 7-0 D/A BV175-6 EP
• Type of Device: 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18970127
• MDR Text Key: 338551017
• Report Number: 2210968-2024-03423
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10705031206786
• UDI-Public: 10705031206786
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EP8735H
• Device Lot Number: TEBHDP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1