MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC VELOSORB FAST; BRAIDED FAST ABSORBABLE SURGICAL SUTURE

Model Number	CV-606
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product will not be returned for investigation.The lot number was requested from the customer multiple times but was not provided, and therefore production records could not be reviewed.A cause for the event cannot be established.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "it was reported that during the perineal tears in the delivery room, the suture line did not hold 12 days postoperatively, which was alleged to have caused infections.The sutures involved were identified as velosorb* 2-0 und 90cm gs25 x36 and velosorb* 2-0 und 90cm kv34 x36.A new suture was used to resolve the issue.".

• Brand Name: VELOSORB FAST
• Common Device Name: BRAIDED FAST ABSORBABLE SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 21699239
• Report Number: 3006981798-2025-00011
• Device Sequence Number: 15612273
• Product Code: GAM
• UDI-Device Identifier: 10884521152304
• UDI-Public: 10884521152304
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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 Model Number: CV-606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown