MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 7 reports linked to mfg report numbers: 3013886523-2024-00289, 3013886523-2024-00290, 3013886523-2024-00292, 3013886523-2024-00296, 3013886523-2024-00297, 3013886523-2024-00298.A patient reported a valve (unknown id), ventricular catheter (unknown id) and a peritoneal catheter (unknown id) was implanted on (b)(6) 1997.In (b)(6) 2024, the patient had indication of failing valve and catheters.The patient underwent 6 revisions, 5 of which were caused by his body rejecting the catheter and it was draining cerebrospinal fluid (csf) outside the cavity and under the skin where it could not be absorbed.Revisions: #1 - (b)(6) 2024: old valve and ventricular catheter were replaced with a codman valve (unknown id) and bactiseal peritoneal catheter (id 823074).#2 - (b)(6) 2024: catheter was expelled from the peritoneal cavity and was repositioned.#3 - (b)(6) 2024: old ventricular catheter was replaced.#4 - (b)(6) 2024: catheter was expelled from the peritoneal cavity and was repositioned.#5 - (b)(6) 2024: catheter was expelled from the peritoneal cavity and reinserted into the pleural cavity.#6 - (b)(6) 2024: catheter was expelled from the pleural cavity therefore, it was removed.Valve was capped and an etv (endoscopic third ventriculostomy) procedure was performed.The patient tested positive for allergy to clindamycin.Note from manufacturer: this reports is for revision #2.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The peritoneal catheter (id 823074) was not returned for evaluation, as per customer, product not available; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined, however, the possible root cause for the issue reported by the customer could be due to user¿s error, possible when connecting the catheters.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.
Additional Manufacturer Narrative
This follow-up is to include updated fields: g4 (combination product): yes.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20274611
• Report Number: 3013886523-2024-00288
• Device Sequence Number: 17011572
• Product Code: JXG
• UDI-Device Identifier: 10381780515630
• UDI-Public: (01)10381780515630(17)241031(10)7314890
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 823074
• Device Lot Number: M8789400A001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 02/27/2025; 04/02/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 03/21/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White