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

Catalog Number 828806

Device Problem No Flow (2991)

Patient Problem Injury (2348)

Event Date 07/21/2020

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 no flow of a certas valve: the valve was implanted via l-p shunt in 2020 with unknown setting to treat subarachnoid hemorrhage.After implantation (unknown date) the patient presented with chronic hematoma; therefore, the valve was changed to vo.In (b)(6) 2020, as the patient's status improved, the setting was changed to 6 from 7.In (b)(6) 2020, the patient started with walking difficulty.When pumping the reservoir, it was slow to back and there was no flow to the peritoneal side when contrast agent was added.The valve was replaced on (b)(6) 2020.The patient also developed infection, treated with antibiotics.

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).The certas valve was returned for evaluation: device history record (dhr)- review of records for the valve was not possible as the lot number and was unknown.Failure analysis- the valve was visually inspected, needle hole in the needle chamber was noted.The valve passed thetest for programming, flushing, reflux, siphon guard and pressure.The vlave was leak tested and only leaked from the needle hole in the needle chamber.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.No root cause could be determined for the infection reported by the customer as the lot number was unknown.The possible root cause for the problem reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.

• 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: 10381872
• MDR Text Key: 202229458
• Report Number: 3013886523-2020-00036
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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: 08/14/2020
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SILASCON LUMBAR CATHETER-MANUF KANEKA-CODE702JJ
• Patient Age: 77 YR