MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 4-0 D/A RB-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3557H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 the patient underwent aortic arch repair procedure on an unknown date and suture was used.During routine use, the suture deswaged and came off in the middle of running a suture line during aortic arch replacement.There were no adverse patient consequences reported.

• Brand Name: PRNVA BLU 36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9281616
• Report Number: 2210968-2019-89551
• Device Sequence Number: 2524195
• Product Code: GAW
• UDI-Device Identifier: 10705031004504
• UDI-Public: 10705031004504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 3557H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1