MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 09/08/2020

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 that on september 3, 2020 the certas valve was implanted via an l-p shunt with a setting of 3.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2020 the valve setting was unable to be change from 3.Therefore, the valve was replaced with a new one.

Manufacturer Narrative

Udi: (b)(4).The certas valve was returned for evaluation: failure analysis: the valve was visually inspected; needle holes in the needle chamber were noted.The valve passed the tests for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested; only leaked from the needle holes in the needle chamber.The catheter was irrigated, no occlusions noted.No root cause could be determined for the problem reported by the customer as the technician could not confirm any programing issues with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism, but at the time of investigation no programing issues were noted.

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10580078
• MDR Text Key: 208332325
• Report Number: 3013886523-2020-00125
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SILASCON LUMBAR CATH MANUF KANEKA, PROD: 702-JJ; SILASCON LUMBAR CATH MANUF KANEKA, PROD: 702-JJ