MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8745
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 (b)(6) 2020 and suture was used.During the procedure, the suture broke during sewing of bridging vascular tissue.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV175-8 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11339930
• Report Number: 2210968-2021-01520
• Device Sequence Number: 13714704
• Product Code: GAW
• UDI-Device Identifier: 10705031134836
• UDI-Public: 10705031134836
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: No Information
• Device Model Number: EPM8745
• Device Catalogue Number: EPM8745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/17/2021
• Patient Sequence Number: 1