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

Catalog Number NS0338

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hydrocephalus (3272)

Event Date 11/17/2021

Event Type  Injury  

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 Description

2 of 3 reports.Other mfg report numbers: 3013886523-2021-00534, 3013886523-2021-00536.A physician reported a hakim valve was implanted via v-p shunt on unknown date with unknown setting.The set pressure could be changed to 30 mmh2o, and the flow could be confirmed, but the symptoms of hydrocephalus did not improve, therefore, the valve was removed and replaced on (b)(6) 2021.The device was used with ns0338 (serial; unk) and ns0339 (serial; unk).

Manufacturer Narrative

The bactiseal ventricular catheter (id ns0338) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.The catheter was leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the catheter, at the time of investigation the no functional issues were noted with the catheter.

Event Description

N/a.

• Brand Name: BACTISEAL BARIUM STRIPED VENT
• Type of Device: 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: 12918715
• MDR Text Key: 285810955
• Report Number: 3013886523-2021-00535
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: NS0338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1