MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT

Catalog Number 823072

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)

Event Date 07/09/2020

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

2 of 2 reports.Other mfg report number: 3013886523-2020-00024.A physician reported infection and cerebral spinal fluid retention: the certas valve was implanted with using bactiseal catheter(823072) via v-p shunt on (b)(6) 2020 with an unknown setting.However, on (b)(6) 2020, infection and csf retention under the skin were observed.The setting was changed to 1 but the csf flow could not be confirmed.Therefore, the valve will be replaced to a new one (competitor's one) on (b)(6) 2020.The physician confirmed that the setting could be changed and setting was 1 after the procedure.The protein concentration was 400 due to infection.

Event Description

N/a.

Manufacturer Narrative

Unique device identification (udi) : (b)(4).The bactiseal catheter was returned for evaluation: device history record was not possible as the lot number was unknown.Failure analysis - the catheters were irrigated, no occlusions noted.The catheters were leak tested, no leaks noted.No root cause could be determined as the technician was unable to confirm the problem reported by the customer.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 device, but at the time of investigation no issues were noted.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Type of Device: BACTISEAL CATHETER KIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10352805
• MDR Text Key: 201528855
• Report Number: 3013886523-2020-00025
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823072
• 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