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

Catalog Number 828806

Device Problem Material Rupture (1546)

Patient Problem Hydrocephalus (3272)

Event Date 12/28/2020

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 facility reported a shunt malfunction.A certas plus programmable in line valve was implanted in a patient via a lumbar peritoneal shunt in (b)(6) 2020 with an unknown initial setting.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).After the procedure, there was no problem observed on the ct scan.On an unknown recent date, the patient fell from a bicycle and hit their back.Reportedly, the patient¿s hydrocephalus symptoms worsened.The details of the hydrocephalus symptoms were not available.The patient was taken to the operating room and the valve was replaced with a new certas valve via a ventricular peritoneal shunt on (b)(6) 2020.During the operative procedure, it was found that the lumbar catheter was ruptured around the spinous process.A part of catheter was remained in the dura.The catheter which was able to be removed was removed and the valve replacement procedure was finished.

Manufacturer Narrative

The certas valve was returned for evaluation: review of the history device records for the lot 4469521, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; needle holes were noted in the needle chamber.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, refux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.No possible root cause could be determined as there was no identified valve failure, the complaint was based on ¿it was found that the lumbar catheter was ruptured around the spinous process.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj) the lumbar catheter is not a codman device.

• 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: 11174355
• MDR Text Key: 227077988
• Report Number: 3013886523-2021-00023
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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: 02/15/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SILASCON LUMBAR CATH(MANUF KANEKAPROD CODE: 702-JJ