MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV CYL W/RR UN120CM DIST

Catalog Number 823851

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Headache (1880); Injury (2348)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported excessive drain of a hakim valve.The valve was implanted to a (b)(6) year-old female at another facility and the patient consulted the physician for a second opinion due to constant headaches.The valve was stuck at 30mmh20 and after several reprogrammings, it was changed to 200mmh20.However the patient continued to drain excessively even when in 0 position.On (b)(6) 2020 the valve was explanted and replaced with a certas plus.

Manufacturer Narrative

The valve was returned for evaluation: device history record (dhr) - product code 82-3851 with lot number ctjbrd, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; biological debris was noted inside the valve as well as needle holes in the needle chamber.The position of the cam when valve was received was at 200mm h2o.The valve was hydrated.The valve was tested for programming and failed, the cam mechanism did not move during the programming process and was stuck at 200mm h2o.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for occlusion, reflux and pressure.The valve was tested again for programming; the valve passed the 2nd test.Biological debris was noted inside the casing, on the spring, on the ruby ball, on the cam mechanism and on the base plate.The excessive drainage could not be confirmed since the pressure test was correct at setting 200mm h2o, nevertheless a malfunction of the valve was confirmed due to programming difficulties.The root cause for the programming problems noted during the investigation was due to biological debris noted inside the casing, on the spring, on the ruby ball, on the cam mechanism and on the base plate.The possible root cause for the malfunction reported by the customer "drain excessively" was probably due to biological debris was avoiding the ruby ball from being seated correctly.As specified in the ifu, adverse events section: "devices for shunting csf might need to be replaced at any time due to medical reasons or failure of the device.Keep patients with implanted shunt systems under close observation for symptoms of shunt failure.Accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting".

Event Description

N/a.

• Brand Name: CHPV CYL W/RR UN120CM DIST
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11120862
• MDR Text Key: 225280769
• Report Number: 3013886523-2020-00301
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K122118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 823851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR