MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 DA V-5 10PLG; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PXX52N
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: (b)(6) 2022.Component code: (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.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 information was requested, and the following was obtained via: there were no adverse consequences associated with the patient.The needles are cut off after the are used to sew the valve in.The ¿pledgetts¿ on the suture seemed thicker than the corresponding product that we have always used.The package lists the thickness as 1.5 mm which is the same as the other product we have used.However the surgeon complained that the pledgetts seemed thicker to him.The issue was noted during use on the patient.The entire package had thicker pledgetts.There are no photos.I don¿t have the package with the lot number.The procedure was an aortic valve replacement and coronary artery bypass grafting (b)(6) 2022.
Event or Problem Description
It was reported that a patient underwent a cabg procedure (b)(6)2022.And pledgetts were was used.During the procedure, it was reported by the customer that the swedges on the sutures are too thick.The ¿pledgetts¿ on the suture seemed thicker than the corresponding product.The package lists the thickness as 1.5 mm which is the same as the other product.However; the surgeon complained that the pledgetts seemed thicker to him.The issue was noted during use on the patient.There were no patient consequences reported.Additional information was requested.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 DA V-5 10PLG
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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
• MDR Report Key: 14189575
• Report Number: 2210968-2022-02899
• Device Sequence Number: 14554840
• Product Code: GAT
• UDI-Device Identifier: 10705031462243
• UDI-Public: 10705031462243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2022

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 Model Number: PXX52N
• Device Catalogue Number: PXX52N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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