MAUDE Adverse Event Report: RAYNHAM BACTISEAL BARIUM STRIPED VENT; BACTISEAL VENTRICULAR CATHETER

Model Number	NS0338
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Edema (4403)
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
1 of 2 reports.Other mfg report number: 3013886523-2021-00447.A physician reported a patient had a blockage requiring revision surgery.The bactiseal ventricular catheter and the codman precision valve with siphonguard have been implanted via vp shunt for 7 weeks in a patient who¿s been treated for a tumor.The patient has not been active and he presented with a fluid collection and symptoms of high intracranial pressure.A revision surgery was performed and it was found that the valve is almost completely sheared in half.It was sitting on the top of his head, not in a mobile area.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal ventricular catheter was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined; however, the possible root cause for ¿occlusion." issue reported by the customer, could be due to biological debris and protein build up interfering with the device.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): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12686923
• Report Number: 3014334038-2021-00212
• Device Sequence Number: 4051524
• Product Code: JXG
• UDI-Device Identifier: 10886704045151
• UDI-Public: 10886704045151
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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 Model Number: NS0338
• Device Catalogue Number: NS0338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 10/24/2021
• Supplement Report FDA Received Date: 04/12/2022
• 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
• Patient Sex: Unknown