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

Model Number 823072

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2023

Event Type  Injury  

Event Description

2 of 2 reports.Other mfg report number: 3013886523-2023-00119 a physician reported a certas valve (id 828814) was implanted in a 49 year-old female patient via ventriculo-peritoneal shunt on february 24, 2023 with unknown setting.It was used with bactiseal catheter (id 823072).Since the skin on the head became thin and the valve became visible under the skin, the shunt system was removed and replaced on (b)(6) 2023.According to information provided, it is unknown if the patient experienced any signs and symptoms.

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

N/a.

Manufacturer Narrative

The bactiseal catheter (id 823072) was returned for evaluation.Failure analysis - the catheters were visually inspected; no defect was noted.The catheters were irrigated, no occlusion noted.The catheters was leak tested; the leak tested passed.No root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.

• 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: 16765921
• MDR Text Key: 313559245
• Report Number: 3013886523-2023-00120
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: 10381780515616
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 823072
• Device Catalogue Number: 823072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 49 YR
• Patient Sex: Female