MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CODMAN BACTISEAL CATHETER KIT

Catalog Number 823072

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

Patient Problem Impaired Healing (2378)

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 3 reports.Other mfg report numbers: 3013886523-2021-00186, 3013886523-2021-00188.A facility reported that the physician placed a shunt on (b)(6) 2021 via a ventricular peritoneal shunt and the wounds did not heal.The timeframe between implantation and onset of symptoms was unknown.The patient had a revision surgery a couple weeks ago and placed a new shunt and new catheters and the patient still will not heal.In fact, the patient seems to be rejecting the catheters on the scalp as well as in the abdomen.The interventions and treatment for the wound were unknown.

Manufacturer Narrative

Udi: (b)(4).The bactiseal catheter was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.However some photos were provided that seems to confirm that "wounds did not heal", it was nevertheless not possible to link those photos to the first or second complaint concerning the issue and it was not possible to clearly determine the root cause without return of the product.The cause(s) of the difficulty reported by the customer could not be determined.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 CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11739784
• MDR Text Key: 247781894
• Report Number: 3013886523-2021-00187
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: 823072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1