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

Catalog Number 823072

Device Problem Insufficient Information (3190)

Patient Problems Cerebral Ventriculomeglia (2133); Ambulation Difficulties (2544)

Event Date 08/30/2021

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

2 of 2 reports.Other mfg report number: 3013886523-2021-00396.A physician reported a certas valve and a bactiseal catheter were implanted to a (b)(6) female due to subarachnoid hemorrhage (sah) via v-p shunt on (b)(6) 2021 with setting 5.Due to gait disturbance, shunt imaging was performed on august 10th and ventricular enlargement was confirmed.The ventricles did not shrink, and the set pressure was finally reduced to 2, but the ventricular size did not change.The patient is in the follow up.

Manufacturer Narrative

The bactiseal catheter (id (b)(6) was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to the connector at the distal end that may have been damaged during placement.Also possibly biological debris interfering with the device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12484798
• MDR Text Key: 271858934
• Report Number: 3013886523-2021-00397
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Sex: Female