MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL VENTRICULAR CATHETER

Catalog Number 823073

Device Problem Infusion or Flow Problem (2964)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 11/07/2020

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

3 of 3 reports.Other mfg report numbers: 3013886523-2020-00273, 3013886523-2020-00274.A physician reported the hakim peritoneal catheter was implanted and connected to a certas valve (product id: 828804, lot#: 4739012) and bactiseal (product id: 823073, lot#: 4397529) to the patient via v-p shunt on (b)(6) 2020 with an unknown setting.However, infection was observed at the peritoneal site and furthermore, csf flow to the peritoneal side could not be confirmed.Therefore, the valve was replaced to a new one on an unknown date.Type of infection/organism unknown.Treatment and or medication given for the infection is unknown.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The valve was returned for evaluation: device history record (dhr): lot number crdcnv, conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; the valve was received dismantled in 3 parts: the silicone housing was cut/torn from the black arrow mark to the distal end of the silicone as well as a tear/cut was noted in the needle chamber, the casing with mechanism inside and the siphon guard were returned outside of the silicone housing.Marks were noted on the siphon guard.The siphon guard was tested and failed.The position of the cam when valve was received was 120mm h2o.The valve was tested for programming, the valve failed the test, the cam mechanism did not move during the programming process.Due to the damaged silicone housing the valve could not be tested for occlusion, leak and reflux.The siphon guard was dismantled and a biological debris was noted blocking the siphon guard.The cam mechanism was slightly moved.The valve was re-tested for programming, the valve failed the test.The cam mechanism did not move during the programming process.The valve mechanism was dismantled and biological debris was found on the spring, on the ruby ball, on the seat of the ruby ball, on the cam mechanism and on the base plate.The cam magnets were inspected and passed.The root cause for "valve occlusion was suspected and it was unable to change the setting.Also, it was confirmed that the cam was not rotating" was due to biological debris was found on the spring, on the ruby ball, on the seat of the ruby ball, on the cam mechanism and on the base plate, as well as biological debris was found blocking the siphon guard.The probable root cause for the cut/torn noted in the silicone housing as well as the cut/tear noted in the needle chamber was probably caused by a hard knock on the device or sharp/pointed object coming into contact with the silicone housing.As specified in the ifu, silicone has a low cut/tear resistance.The possible root cause for marks were noted on the siphon guard may be linked to the use of a toothed or sharped object.Complaint will be closed as 'blocked/occluded: biologic debris: after implantation'.

Event Description

N/a.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Type of Device: BACTISEAL VENTRICULAR CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11074136
• MDR Text Key: 223718170
• Report Number: 3013886523-2020-00275
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 823073
• Device Lot Number: 4397529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1