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

Catalog Number	823074
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Vomiting (2144); Confusion/ Disorientation (2553)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2023-00231, 3013886523-2023-00240.A physician reported a certas valve (id 828804), a peritoneal catheter (id 823074) and a ventricular catheter (id 823073) were implanted via ventricular peritoneal (vp) shunt on (b)(6) 2023.On (b)(6) 2023, the patient had a headache and slit ventricle appeared.On (b)(6) 2023, an x-ray was performed because the patient presented with disorientation.The setting pressure was set to 8 because a slit-like ventricle was observed; acute hydrocephalus occurred.On (b)(6) 2023, an x-ray was performed because the patient presented with vomiting.Due to ventricular enlargement, drainage was performed.An obstruction was suspected therefore, the valve, the peritoneal and ventricular catheter were removed and replaced on (b)(6) 2023.
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 catheter (id 823074 ) was returned for evaluation.Failure analysis - the catheter was visually inspected and no defect was noted.The catheter was irrigated, no occlusion and leak 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.
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: 17395977
• Report Number: 3013886523-2023-00239
• Device Sequence Number: 5931815
• Product Code: JXG
• UDI-Device Identifier: 10886704041337
• UDI-Public: 10886704041337
• 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): 09/07/2023

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
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Female