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

Catalog Number 823072

Device Problem Obstruction of Flow (2423)

Patient Problems Failure of Implant (1924); Cerebral Ventriculomeglia (2133)

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

1 of 2 reports.Other mfg report number: 3013886523-2021-00299.A physician reported a hakim programmable in-line valve was implanted in a patient via ventricular peritoneal shunt on (b)(6) 2021 with an unknown initial setting.The valve was used with catheter 823072 (serial; unknown).The patient¿s condition was reported as stable one week after the operation.Ventricular enlargement was observed radiographically on (b)(6) 2021.No improvement in the ventricular enlargement was seen after changing the shunt valve pressure.There were not clinical symptoms of hydrocephalus other than the ventricular enlargement.The shunt was diagnosed as clogged by pumping.The patient was taken to the operating room for a shunt and catheter revision surgery on (b)(6) 2021.The patient is in ¿good condition.¿ no further information was provided by the hospital.

Event Description

N/a.

Manufacturer Narrative

Catheter was returned for evaluation: failure analysis: the catheters were visually inspected; some biological debris was noted near two of the ventricular catheter holes.The catheters were irrigated, no occlusions noted.Root cause: no root cause could be determined as the technician could not confirm any problem with the catheters at the time of investigation.The possible root cause for the issue ¿the shunt was diagnosed as clogged by pumping¿ reported by the customer, could be due to biological debris and protein build up interfering with the catheters, at the time of investigation no occlusion 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: 12148178
• MDR Text Key: 267668984
• Report Number: 3013886523-2021-00300
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1