MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA; CHPV WITH SG

Catalog Number NS9008

Device Problem Infusion or Flow Problem (2964)

Patient Problems Injury (2348); Confusion/ Disorientation (2553)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported occlusion of a hakim valve: the valve was implanted via l-p shunt on (b)(6) 2019 with an initial setting of 110mmh2o.On (b)(6) 2020, the patient was found to be disorientated and a contrast study showed cerebral ventricular enlargement.The valve setting was changed, but the patient's clinical symptoms did not change, so contrast medium was flushed to confirm csf flow.No contrast flow could be seen at the end of the abdominal cavity, and occlusion was suspected.Therefore, it was replaced with a new valve.The patient is doing well.

Manufacturer Narrative

Udi : (b)(4).Dhr - was not possible as the lot number was unknown.Failure analysis - the valve was visually inspected, needle holes in the needle chamber were noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested: only leaked from the needle holes in the needle chamber.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The potential cause of failure for the occlusion problem reported by the customer could have been due to biological debris and a buildup of protein, no issues were noted during the investigation.

• Brand Name: SPECIAL DEVICE UNITIZED PROGRA
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10406755
• MDR Text Key: 202882389
• Report Number: 3013886523-2020-00046
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NS9008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1