MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR OSV II

Catalog Number	909708S
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the implanted catheter of the osv ii (909708s) was weak/fragile and dislocated when handling even if medical staff used sheathed forceps.The catheter tore and needed to be changed; thus, the patient was moved to operating room to change the valve (dysfunction of the valve).
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The osv ii (b)(6) catheter was returned for evaluation: device history record (dhr) ¿ review of the history device records for the product code (b)(6) with lot 0226321, conformed to the specifications when released to stock.Failure analysis - the investigation of the unit confirmed the complaint: the returned product was decontaminated, and the device was visually inspected.No defect was noted; however, a tear/cut was noted on the end of the catheter.Root cause --the root cause for the issue reported by the customer, is due to improper handling of the device in view of the cut or is due to a sharp or pointed object coming into contact with the valve.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: OSV II
• Common Device Name: OSV II
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17217772
• Report Number: 3013886523-2023-00200
• Device Sequence Number: 16900111
• Product Code: JXG
• UDI-Device Identifier: 10381780035480
• UDI-Public: 10381780035480
• Combination Product (Y/N): N
• PMA/510(K) Number: K971799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2024
• Device Catalogue Number: 909708S
• Device Lot Number: 0226321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown