MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL BARIUM STRIPED VENT; BACTISEAL VENTRICULAR CATHETER

Catalog Number	NS0338
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/12/2024
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
A physician reported a bactiseal (unknown id) was implanted via ventriculoperitoneal (vp) shunt on (b)(6) 2024.The patient developed pancytopenia, and obstructive hydrocephalus was developed due to a brain tumor.The bactiseal remains implanted.According to information provided, it is unknown if there was any identified issue with the device.The patient status is unknown.
Additional Manufacturer Narrative
Additional information received: - the patient was treated by g-csf twice for pancytopenia.- all devices were removed on 27 march, however, it was unknown whether new valve and catheters were implanted.- the patient condition was currently stable.- all medicines the patient took before were changed to different ones.The patient had pancytopenia after bactiseal implanted, and the physician suspected that bactiseal was related to pancytopenia.The patient condition is stable after removed.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal catheter was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.However, a possible root cause for the issue reported by the customer could be due to implant used on patient with material sensitivity.However, it was not possible to confirm and identify the root cause of this assumption as the product was not returned for investigation.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.

• Brand Name: BACTISEAL BARIUM STRIPED VENT
• Common Device Name: BACTISEAL VENTRICULAR CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19028965
• Report Number: 3013886523-2024-00098
• Device Sequence Number: 6992567
• Product Code: JXG
• UDI-Device Identifier: 10381780524052
• UDI-Public: 10381780524052
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NS0338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 05/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/19/2024; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CERTAS PLUS (ID 828804)
• Patient Age: 60 YR
• Patient Sex: Unknown