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 Problem Cerebral Ventriculomeglia (2133)

Event Date 07/16/2021

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

3 of 3 reports.Other mfg report numbers: 3013886523-2021-00352, 3013886523-2021-00353.A physician reported enlargement of the ventricles of a patient with a bactiseal catheter.The catheter was used together with the 823073 (catheter) and 823162 (hakim valve).The valve was implanted to the patient via v-p shunt this year with unknown setting.The enlargement of ventricles was confirmed, therefore, the set pressure was changed.After several days there was no change in the ventricles.The catheter was also replaced on (b)(6) 2021.

Manufacturer Narrative

Udi: (b)(4).The bactiseal catheter was returned for evaluation: failure analysis - the catheter was visually inspected; no defect was noted.It was noted that only 23mm of distal catheter attached to the valve was received.When detached, only 14mm of catheter was available for testing.The catheter was irrigated and no occlusion was noted.The catheter was leak tested and passed.No leakage was noted.Note that due to the short length of catheter and because of connectors length, only about 6mm of catheter was leak tested.No issue was noted.No root cause could be determined as the technician could not confirm any problem at the time of investigation with the little piece (23mm) of distal catheter returned.The possible root cause for the "enlargement of the ventricles" reported by the customer could be due to biological debris and protein buildup interfering with the device.But, at the time of investigation, no occlusion issue was noted.As noted in the "ifu", in the section 'complications': "in addition, shunt revisions have been necessitated by the following complications associated with peritoneal catheters: subcutaneous kinking, fracture, obstruction of the distal end, and retraction of the distal end from the peritoneal cavity".

• 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: 12291380
• MDR Text Key: 265567738
• Report Number: 3013886523-2021-00354
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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: 08/18/2021
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1