MAUDE Adverse Event Report: ETHICON INC. PROLENE MONO BLUE HEMO; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D9996
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Not Applicable (3189)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient underwent artificial vascular anastomosis of the abdominal aorta on an unknown date and suture was used.During the procedure, the artificial vascular was anastomosed by continuous suturing on the abdominal aorta.After the primary surgery, ct examination was done regularly, and a false aneurysm was found about 1 year and 2 months after the surgery.After 1.5 years post-op, reoperation was performed because the patient¿s condition became worse.On (b)(6) 2018, the patient underwent reoperation and suture which was used in the primary operation was broken other than knot.The suture was removed and the procedure was completed with another unknown suture.The patient is hospitalized currently.The doctor opined that a false aneurysm has occurred due to breaking of the suture at the anastomotic site.After reoperation, the patient has recovered steadily.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The following information was requested but unavailable: can you explain ¿patient¿s condition became worse¿? no further information.What was the indication for the second procedure? no information.Can you describe the suture during the second procedure? no information.What was used to close the anastomosis? no information.What are the patient age, gender, weight, medical history? no information.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.A suture piece of product code (b)(4) was returned for analysis.During the visual inspection of the sample, wavy suture and a knot were noted.Also, the ends were cut, appeared to be by use of surgical instrument, this is consistent with the suture being pulled to remove from the patient.In addition, a functional test was performed and the tensile force were above the minimum requirements.The manufacturing records couldn¿t be reviewed as the batch number is unknown.No conclusion could be reached as to what may have caused the reported incident.

• Brand Name: PROLENE MONO BLUE HEMO
• 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: 7658401
• Report Number: 2210968-2018-74021
• Device Sequence Number: 10796757
• Product Code: GAW
• UDI-Device Identifier: 10705031134560
• UDI-Public: 10705031134560
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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: D9996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 07/25/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/20/2018; 08/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention