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

Catalog Number	823072
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erythema (1840); Bowel Perforation (2668)
Date of Event	05/11/2023
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
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2025-00134.Event received from a post-market clinical program: a facility reported a hakim valve (id 823832) and a bactiseal catheter (id 823072) were implanted on (b)(6) 2022.One year after implantation procedure, (b)(6) 2023, the patient was admitted due to redness, swelling, and pain in the right upper abdominal wall.A routine color doppler ultrasound revealed localized fluid accumulation in the right upper abdominal wall, suggesting possible displacement of the abdominal end of the vp shunt.On (b)(6) 2023, the patient underwent vp shunt revision, exploratory laparotomy, intestinal perforation repair, omental release, and drainage of an abdominal wall abscess.Intraoperative findings showed that the abdominal end of the shunt catheter was partially transected, and the distal end was externalized and connected to an indwelling needle catheter and rubber tube for continuous drainage.Abscess cultures identified streptococcus anginosus and escherichia coli.Postoperative management included intensified antibiotic therapy, and follow-up imaging on (b)(6) 2023, indicated satisfactory recovery, leading to the patient¿s discharge on the same day.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Corrected field: g2.The codman 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 "irrelevant" (not related to the bactiseal catheter 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: 22201634
• Report Number: 3013886523-2025-00135
• Device Sequence Number: 12673486
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: (01)10381780515616(17)221130(10)6014268
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• 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: 11/30/2022
• Device Catalogue Number: 823072
• Device Lot Number: 6014268
• 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: 05/22/2025
• 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: 12/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HAKIM VALVE (ID 823832)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian