MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	04/30/2024
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 peritoneal catheter (id 823074) and certas valve (id 828804) were implanted via lumbar peritoneal (lp) shunt due to secondary normal pressure hydrocephalus (snph) on (b)(6) 2024, with unknown setting.The valve was used with silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).Underdrainage caused ventricular dilatation after the surgery, and the patient's clinical condition worsened.A new valve was implanted via ventricular peritoneal (vp) shunt on (b)(6) 2024, due to suspicion of device obstruction.The blood clot was observed inside the explanted valve.Although a flow test was conducted on the explanted lumbar catheter, flow could not be confirmed.According to the doctor, lumbar punctures were performed repeatedly during the surgery on (b)(6) 2024, which may have caused an influx of bloody cerebrospinal fluid (csf) into the shunt device.The patient's primary disease is subarachnoid hemorrhage and is currently in a follow-up status.According to information provided, it is not known if the obstruction was observed in the peritoneal catheter.It is also unknown if the catheter was removed and replaced.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected no defects noted.The catheter was irrigated, biological debris was flushed out, flow was very slow partially occluded.Root cause analysis - the potential root causes for the reported issue reported by the customer is probably due to the biological debris found inside the catheter.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19391935
• Report Number: 3013886523-2024-00149
• Device Sequence Number: 7753680
• Product Code: JXG
• UDI-Device Identifier: 10381780515630
• UDI-Public: 10381780515630
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 07/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/19/2024
• 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 828804; SILASCON LUMBAR CATHETER (KANEKA, CODE: 702-JJ).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female