MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV UNITIZED

Catalog Number 823114

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebral Ventriculomeglia (2133)

Event Date 12/01/2020

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 physician reported a hakim valve was implanted on june 1, 2017 via v-p shunt to a 3 years-9 months male patient to treat congenital hydrocephalus.The initial setting was 80mmh2o.In (b)(6) 2020, ventricular enlargement and csf retention were observed.So, the setting was tried to change by hakim programmer, but it could not be changed.Therefore, it was changed by a neodymium magnet to 30mmh2o.In (b)(6) 2020, as the symptoms did not improve, the setting was tried to change.However, it could not be changed.Therefore, the valve was replaced with a new one on (b)(6) 2020.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The valve was returned for evaluation.Device history record (dhr): lot 109841, conformed to the specifications when released to stock failure analysis: the position of the cam when valve was received was 30mmh2o.The valve was visually inspected: some biological debris was noted.The valve was hydrated.The valve passed the test for programming, occlusion and leaks.The valve failed the test for reflux and pressure.The valve was dismantled and was examined under microscope at appropriate magnification and a biological debris was found in the housing on the spring, on the spring pillar, on the ruby ball on the seat of ruby ball and on the base plate.The root cause for the pressure issue noted during the investigation is due to the biological debris found on the spring, on the spring pillar and on the ruby ball, the biological debris was not letting the ruby ball sit correctly.The possible root cause for the issue reported by the customer could be biological debris and protein build up interfering with the valve mechanism, at the time of the investigation no programing issues were noted.

• Brand Name: MICRO CHPV UNITIZED
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11073258
• MDR Text Key: 223730455
• Report Number: 3013886523-2020-00269
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 823114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR