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

Model Number	VP-630-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: during bypass ( anastomosis) open procedure, the thread got broke.The suture was not hydrated prior to use.No component fell into the patient cavity.An x-ray was performed.The surgical time was extended due to the product problem, the product was replaced with the new one (same model, different lot number) in order to complete the case, no injury.Patient status: alive - no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection and functional evaluation of the products had acceptable results.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO LL
• 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: 6615533
• Report Number: 9612501-2017-05586
• Device Sequence Number: 13638142
• Product Code: GAW
• UDI-Device Identifier: 10884521038042
• UDI-Public: 10884521038042
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2017

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: 10/31/2021
• Device Model Number: VP-630-X
• Device Catalogue Number: VP-630-X
• Device Lot Number: D6K2509X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 06/21/2017; 06/21/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/18/2017; 10/04/2017
• 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: Other; Required Intervention