MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL CATHETER KIT

Catalog Number	823072
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Abdominal Distention (2601)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Event reported from a post-market clinical program: a facility reported a bactiseal catheter kit (id 823072) and a hakim valve (id 823832) were implanted on (b)(6) 2021 due to hydrocephalus with an initial successful outcome.The patient noticed progressive abdominal wound bulging, and abdominal x-ray revealed coiling of the shunt catheter.The patient was admitted for elective surgery, and on (b)(6) 2022, underwent vp shunt repositioning surgery.Postoperatively, the patient received antibiotic therapy, fluid replacement, and symptomatic management, and was discharged on (b)(6) 2022 with all implanted devices remaining in place.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Corrected field: g2.The bactiseal catheter was not returned for evaluation as the product is not available for return as per customer; 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.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 information received: the physician has changed the correlation decision of this event from ¿relevant¿ to ¿possibly irrelevant¿ (not related to the bactiseal catheter kit - id 823072).

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: BACTISEAL CATHETER KIT
• 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: 22202031
• Report Number: 3013886523-2025-00145
• Device Sequence Number: 17831438
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: (01)10381780515616(17)220228(10)5379684
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 823072
• Device Lot Number: 5379684
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2021
• 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 Sex: Unknown