MAUDE Adverse Event Report: RIVERPOINT MEDICAL, LLC VELOSORB FAST; SUTURE

Model Number	CV-917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the procedure, the episiotomy suture lines was breaking down and there was gaping of lines.It was also reported that the thread broke.Another suture was used to complete the case and resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
A review of the device history record was performed and all products tested met finished goods testing requirements for the lot prior to release.Retained samples from the same lot were tested for tensile strength and all samples passed.A cause of the malfunction could not be established.

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL, LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: eileen mccafferty ; 825 ne 25th ave; portland, OR 97232 ; 5035178001
• MDR Report Key: 13375266
• Report Number: 3006981798-2022-00002
• Device Sequence Number: 5184986
• Product Code: GAM
• UDI-Device Identifier: 10884521151659
• UDI-Public: 10884521151659
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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
• Device Expiration Date: 09/30/2023
• Device Model Number: CV-917
• Device Catalogue Number: CV-917
• Device Lot Number: 20102805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female