MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Model Number 828814PL

Device Problem No Device Output (1435)

Patient Problems Fatigue (1849); Irritability (2421)

Event Type  Injury  

Event Description

A facility reported a certas valve (id 828814pl) was implanted about 6 months ago to treat hydrocephalus.The valve won't reprogram to different setting.Several attempts were made to reprogram to different setting with multiple programmers with no success.The patient was experiencing irritability and fatigue (also had ear infection.Therefore, the valve needed to be revised.

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

N/a.

Manufacturer Narrative

The certas valve (id 828814pl) was returned for evaluation.Device history record (dhr) - the product code 82-8814pl with lot 6160771, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 5.The valve was visually inspected; the rotation construct was in the up position and a tear/cut in the silicone housing around the siphon guard was noted.The valve was tested for programming; the valve failed the test.The valve was hydrated.The valve was leak tested; leaked from the damaged silicone housing.The valve could not be reflux tested, due to damaged silicone housing.The valve passed the test for, occlusion, siphon guard and pressure.The siphon guard was visually inspected, mark were noted on the siphon guard.The valve was dried.The siphon guard was removed.The valve was dismantled and was examined under microscope at appropriate magnification.When dismantled the rotating construct remained fixed to the upper casing, stress marks were noted in the bump mark in the upper casing and the spring has been bent.Root cause - the root cause for the bump mark in the top of the valve casing is due to the valve receiving a knock.The root cause for the rotating construct stuck in the upper position and the bent spring is due to the valve receiving a knock.The root cause for the programing issue reported by the customer is due to the valve receiving a knock.The root cause for the cut/tear in the silicone housing is probably due to a sharp or pointed object, or handling, as noted in the ifu silicone has a low cut/tear resistance, and the root cause for the marks in the siphon guard is due to a sharp or pointed object coming into contact with the siphon guard.

• Brand Name: CRTS SM IL SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• 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: 16263955
• MDR Text Key: 308364921
• Report Number: 3013886523-2023-00021
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: (01)10381780529378(17)270131(10)6160771
• Combination Product (y/n): N
• PMA/PMN Number: K182265
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 828814PL
• Device Catalogue Number: 828814PL
• Device Lot Number: 6160771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1