MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL BARIUM STRIPED CATH; BACTISEAL CATHETER KIT

Catalog Number	NS0340
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
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 catheter (id ns0340) implanted along with a certas valve (id 828814) due to unknown reason via ventriculoperitoneal shunt (vp) on unknown date.A month after the device was implanted, a dysfunction of the device was suspected.A contrast radiography was performed, and obstruction of the device was suspected.Therefore, reoperation was performed, and the device was explanted on unknown date.According to information provided, it is unknown if the bactiseal catheter (id ns0340) was replaced.It is also unknown if the patient experienced any signs and symptoms due to suspected obstruction.The patient recovered.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal barium catheter (id ns0340) was returned for evaluation.Failure analysis - the catheters were visually inspected: no defects noted.The catheters were irrigated, no occlusions noted.The catheter parts were leak tested; no leaks noted.Root cause analysis - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any issues with catheter parts at the time of investigation.A possible root cause for the issue reported by the customer could be due to catheter susceptible to kinking which leads to occlusion.However, it was not possible to confirm and identify the root cause of this assumption as only parts of the catheters were returned, and no issue was identified with the catheter pieces returned.

• Brand Name: BACTISEAL BARIUM STRIPED CATH
• Common Device Name: BACTISEAL CATHETER KIT
• 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: 18966531
• Report Number: 3013886523-2024-00090
• Device Sequence Number: 6571370
• Product Code: JXG
• UDI-Device Identifier: 10381780524076
• UDI-Public: 10381780524076
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NS0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/24/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 VALVE (ID 828814).
• Patient Sex: Unknown