MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV UTZ BACCATH ACC; DEFAULT

Catalog Number 828813PL

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Failure of Implant (1924)

Event Date 10/22/2021

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 customer reported that they were unable to reprogram the certas valve.Patient underwent valve revision.The valve was used to treat hydrocephalus.

Manufacturer Narrative

The certas valve was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 5.The valve was visually inspected a bump mark was noted in the valve upper casing and the rotation construct was stuck in the up position.The valve failed programming test.Root cause analysis: the root cause for the bump mark and cracks in the top of the valve casing, the rotating construct stuck in the upper position, and programming issue is due to the valve receiving a hard knock.

Event Description

N/a.

• Brand Name: CRTS SM IL VLV UTZ BACCATH ACC
• Type of Device: DEFAULT
• 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: 12830435
• MDR Text Key: 280944808
• Report Number: 3013886523-2021-00503
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 828813PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1