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

Catalog Number	823073
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
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 3 of 3 reports linked to mfg report numbers: 3013886523-2023-00231, 3013886523-2023-00239.A physician reported a certas valve (id 828804), peritoneal catheter (id 823074) and 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.The patient was followed up.On (b)(6) 2023, the patient was disoriented therefore, an x-ray was performed.The setting pressure was set to 8 because a slit-like ventricle was observed.On (b)(6) 2023, the patient was vomiting, and an x-ray was performed.Due to ventricular enlargement, the drainage was performed.An obstruction was suspected therefore, the valve, peritoneal and ventricular catheter were removed and replaced on (b)(6) 2023.The patient is followed up.
Additional Manufacturer Narrative
The bactiseal catheter (id 823073) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Common Device Name: BACTISEAL VENTRICULAR 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: 17395974
• Report Number: 3013886523-2023-00240
• Device Sequence Number: 5931813
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: 10381780515623
• 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): 09/15/2023

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: 823073
• Was Device Available for Evaluation?: No
• 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: 09/05/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Female