MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	VP-776-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an endarterectomy, while they were creating an anastomosis using a running technique in suturing, the suture broke easily.Running down the knot was difficult, the device was used twice during the procedure.The anastomosis made with the suture on the back of artery broke.The patient loss more than 500 cc of blood and got two 5 liters of external blood.The time of the procedure was extended more than 30 minutes.Another anastomosis was done, running technique was performed to repair and the same type of suture was used but they used single stitch, interrupted.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the opened sample noted one suture and one needle.It was observed, under magnification, that the suture appeared to have split under tension.The visual inspection and functional evaluation of the sealed sample had acceptable result.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an endarterectomy, while they were creating an anastomosis using a running technique in suturing, the suture broke easily.Running down the knot was difficult, the device was used twice during the procedure.The anastomosis made with the suture on the back of artery broke.The patient loss more than 500 cc of blood and got 2, 5l of external blood.The time of the procedure was extended more than 30 minutes.Another anastomosis was done, running technique was performed to repair, with the same type of suture with the same product id and lot no.A single stitch technique interrupted was used without issue.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7511965
• Report Number: 9612501-2018-00981
• Device Sequence Number: 10833969
• Product Code: GAW
• UDI-Device Identifier: 20884521039268
• UDI-Public: 20884521039268
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: VP-776-X
• Device Catalogue Number: VP-776-X
• Device Lot Number: D7E1200PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 08/09/2018
• 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