MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	10/18/2023
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 number: 3013886523-2023-00381.A physician reported that a certas valve (828804) was implanted on unknown date with unknown setting after a cerebellar hemorrhage.The patient had shunt infection on unknown date.Currently, there is no infection, however a patient had ventricular enlargement.Although setting was changed to 1, but ventricular was still enlarged.Debris was seen in the peritoneal catheter which was removed by flushing.On (b)(6) 2023, the valve and the ventricular catheter (id 823073) were removed and replaced due to suspicion of occlusion, and the peritoneal catheter remained implanted.A 30 minute delay was noted.According to the additional information received, the implantation date of the ventricular catheter (id 823073) is unknown.It is unknown if there is a failure with the peritoneal catheter.It is also unknown if there is a plan to remove the peritoneal catheter.
Additional Manufacturer Narrative
The bactiseal ventricular catheter (id 823073) was returned for evaluation.Device history record (dhr) - review of the history device records for the product code 82-3073 with lot 7028049, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated, no occlusions were noted.The valve was leak tested; no leaks were noted.Root cause analysis ¿ 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 no function issues were noted.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• 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 ; 6099362319
• MDR Report Key: 18142633
• Report Number: 3013886523-2023-00383
• Device Sequence Number: 8045123
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)240131(10)7028049
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 01/19/2024

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 823073
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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 (828804); PERITONEAL CATHETER
• Patient Sex: Male