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

Model Number	VPF-702-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during an open myocardiac revascularization procedure.The suture was treated or hydrated prior to use with serum.The thread of the suture broke three hours into the procedure while performing the normal suture technique.In order to resolve the issue and complete the case, another suture was used without issue.There was no patient harm.The patient outcome is alive, no injury.

• 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: 6951409
• Report Number: 9612501-2017-06418
• Device Sequence Number: 16330040
• Product Code: GAW
• UDI-Device Identifier: 20884521039886
• UDI-Public: 20884521039886
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K010909
• 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
• Report Date (Section B): 10/16/2017

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 Expiration Date: 09/30/2021
• Device Model Number: VPF-702-X
• Device Catalogue Number: VPF-702-X
• Device Lot Number: D6J1387X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1