MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV RT ANG RESERVOIR UNITIZED

Model Number	823148
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported continuous csf over-drainage (200-300ml) even after changing several pressure settings of a hakim valve.The patient developed subdural hematoma; therefore, the valve was explanted on (b)(6) 2022.The valve was implanted to treat secondary hydrocephalus.
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 hakim valve was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined; however, the possible root cause could be biological debris and protein build up interfering with the valve mechanism, as the device has not been returned for investigation this could not be confirmed.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h10 the hakim valve (id 823148) was returned for evaluation.Device history record (dhr) review - review of the history device records for the valve, product code 82-3148 with lot 5635829, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a cut/tear in the silicone housing over the valve casing was noted and a mark in the valve casing, also biological debris.The valve was hydrated.The valve passed the test for programming and occlusion.The valve was leak tested and leaked from the damaged silicone housing.The valve failed the test for reflux and pressure due to the damaged silicone housing.The root cause for the issue reported by the customer, is probable due to the damaged silicone housing.The root cause for the damaged silicone housing is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu, silicone has a low cut/tear resistance.The root cause for the marks in the valve casing are probably due to a sharp or pointed object coming into contact with the valve casing.

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: CHPV
• 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: 14015871
• Report Number: 3013886523-2022-00132
• Device Sequence Number: 6301551
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: (01)10381780519225(17)260531(10)5635829
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 05/31/2026
• Device Model Number: 823148
• Device Catalogue Number: 823148
• Device Lot Number: 5635829
• 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: 03/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 08/30/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 06/02/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2021
• 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 Age: 58 YR
• Patient Sex: Male