MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Cerebral Ventriculomegaly (2133)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3013886523-2024-00013.A physician reported a certas valve (828804) and a bactiseal catheter (823074) were implanted due to communicating hydrocephalus and secondary normal pressure hydrocephalus (snph) via lumboperitoneal shunt on (b)(6), 2023 with setting 2.The patient had headaches and developed ventricle dilation.An obstruction was found, therefore a revision surgery was performed.The valve and the catheter were explanted and replaced with a new certas valve (828804) and a new peritoneal catheter (823074) on (b)(6), 2023.The setting of the valve was 2 when explanted.The patient has recovered.
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.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were found.The catheter was irrigated; no occlusions noted.The catheter was leak tested; no leaks noted.The complaint was unconfirmed.Root cause analysis - no root cause for the issue reported by the customer could be determined as no defects could be found with the piece of catheter that was returned.A possible root cause for the issue reported by the customer could be due to catheter susceptible to kinking which could lead to an occlusion.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18627236
• Report Number: 3013886523-2024-00014
• Device Sequence Number: 8093013
• 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: 2023
• 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): 03/24/2024

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: 823074
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/24/2024
• 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 (828804)
• Patient Age: 67 YR
• Patient Sex: Female