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

Catalog Number 828814

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

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 csf retention and a "skin bump¿: the certas valve was implanted via v-p shunt by end of (b)(6) 2020 with an unknown setting.However, within a month from the procedure, a skin bump was observed at valve implantation site, csf retention was found, and valve detachment was suspected.Therefore, the valve was replaced to a new one on (b)(6) 2020.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h6, h10.Udi - (b)(4).The valve was returned for evaluation: review of the history device records was not possible as the lot number was unknown.Failure analysis - the valve was visually inspected; the silicone housing was cut/torn around the siphon guard.The valve passed the test for programming, occlusion, siphon guard and pressure.The valve was leak tested; leaked from the torn/cut silicone housing.The catheters were irrigated no occlusions noted.The root cause for the cut/tear in the silicone housing was probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The possible root cause for the issue reported by the customer was due to the cut/torn silicone housing, csf fluid was not flowing due to the cut/torn silicone housing hence causing a swelling (bump).

• 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
• MDR Report Key: 10399949
• MDR Text Key: 202710483
• Report Number: 3013886523-2020-00043
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1