MAUDE Adverse Event Report: US SURGICAL PUERTO RICO VP-580-X SURGIPRO II 5-0 BLU 90CM CV15DA; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	VP-580-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when the surgeon used the device with the pusher to go down on a laparoscopic replacement valve of a mitral plasty procedure, the thread of the device broke.Surgical time was extended by 30 minutes or more due to increase time of the device for extra-corporal circulation.Surgeon used another device to resolve the issue.No patient injury.

• Brand Name: VP-580-X SURGIPRO II 5-0 BLU 90CM CV15DA
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 10197058
• Report Number: 2647580-2020-01949
• Device Sequence Number: 11587689
• Product Code: GAW
• UDI-Device Identifier: 10884521037953
• UDI-Public: 10884521037953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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 Model Number: VP-580-X
• Device Catalogue Number: VP-580-X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1