MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSV II (LUMBAR)

Model Number	909710
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that after osv ii lumbar valve (909710) was implanted in a patient on (b)(6) 2021, the pump chamber had a leakage problem.The patient had a scheduled revision after extraperitoneal revision of the drain.The drain was still running, but when the peritoneal catheter was on hold during the preparation of the new intraperitoneale access, liquid was observed every 2-3 seconds leaking out of the silicone sleeve of the pump of the osv ii device.No observable patient symptoms were reported; however, the facility advised that symptoms were linked with extraperitoneal migration of the distal catheter.The patient underwent revision surgery on (b)(6) 2021 where another osv ii device 909710 was placed.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The osv ii lumbar valve (909710) was returned for evaluation: device history record (dhr) - the dhr was reviewed and and did not reveal any anomaly that could explain the reported event.Failure analysis - the investigation of the returned device showed that the reported complaint was verified from the evaluation.The valve was received, without catheters.A tear was observed on the valve silicone elastomer housing close to the serial number.Injection of water in the valve revealed a drop at the level of the tear, evidencing valve leakage.Root cause - each valve is pressure/flow tested at the end of the manufacturing process and this valve was tested within specifications as shown on the device history records.After this final test, valve is disconnected from the test equipment, then packaged and sterilized.The tear aspect could be related to a damage by a nail, but since operators at the manufacturing packaging step and in the hospital operating room wear gloves, the most likely cause could be a manipulation error when disconnecting the valve from the tester during the production phase.Since the review of integra complaint tracking database since 2019 revealed no similar case (for any osv ii valve, ventricular or lumbar) which have been shipped from manufacturing site, the case is considered as an isolated manufacturing error.A resensibilization of the operators will be performed.No further investigation nor corrective action is deemed required on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

• Brand Name: OSV II (LUMBAR)
• Common Device Name: OSV II
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13258001
• Report Number: 9612007-2022-00002
• Device Sequence Number: 19227537
• Product Code: JXG
• UDI-Device Identifier: 10381780034018
• UDI-Public: (01)10381780034018
• Combination Product (Y/N): N
• PMA/510(K) Number: K140722
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: 909710
• Device Catalogue Number: 909710
• Device Lot Number: 0220278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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