MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 30IN 5-0 D/A RB-2 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPH8710H
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
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.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of the index procedure no information.Date and name of the index surgical procedure? the procedure date is unknown.The surgery was for aortic dissection.On what tissue was the suture used? large artery.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? no information.Diagnosis and indication for the index surgical procedure? no information.Was additional medical or surgical intervention required for the torn artery during the surgical procedure? no information.Was there a change in the patient¿s post-operative care as a result of this event? no information.Did the operating surgeon observe any suture anomaly before, during, after the suture placement or during any re-operation? no information.What is physician¿s opinion as to the etiology of or contributing factors to the event? no information.Was this the first time the surgeon used prolene everpoint? no information.Does the surgeon believe that the issue is with the suture or the needle? no, he doesn't.What is the patient¿s current status? there were no adverse consequences to the patient.No further information will be provided.".
Event or Problem Description
It was reported that a patient underwent an aortic dissection procedure on unknown date and suture was used.The surgeon poured water on the suture and the suture did not slide well which tore the large artery.The surgeon opined that there was no issue with the suture.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).It was reported that this device is not malfunction reportable.Therefore, this medwatch report is not reportable.

• Brand Name: PRLNE HS BLU 30IN 5-0 D/A RB-2 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7579547
• Report Number: 2210968-2018-73357
• Device Sequence Number: 2062810
• Product Code: GAW
• UDI-Device Identifier: 10705031233485
• UDI-Public: 10705031233485
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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,Followup
• Report Date (Section B): 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EPH8710H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention