MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Brain Injury (2219); Convulsion/Seizure (4406)
Date of Event	10/19/2007
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 numbers: 3013886523-2023-00247.Medwatch mw5119304: "the reporter called, stating that her daughter has had numerous health problems and reporting medical cover-ups by multiple healthcare personnel and healthcare organizations ever since her daughter was implanted with nervous system shunts and catheters.Reporter states her daughter has had "over 110 high-dose ct scans" of her brain.Reporter states cover-ups by healthcare personnel include a fall that her daughter suffered while being treated in the emergency room, an expired device that was implanted in her daughter, position problems with the catheter, shunts not draining correctly as well as a blocked shunt, and brain damage including encephalomalacia.Reporter states her daughter has suffered "seizures and head pain" and even respiratory failure in 2022.Reporter states she has concerns that "they have never run a shuntogram".Reporter states the device vibrates and causes her daughter pain.".
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h4, h10 the bactiseal ventricular catheter (id (b)(4)) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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 MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17489325
• Report Number: 3013886523-2023-00248
• Device Sequence Number: 7376807
• Product Code: JXG
• UDI-Device Identifier: 10886704041320
• UDI-Public: (01)10886704041320(17)080430(10)
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 04/30/2008
• Device Catalogue Number: 823073
• Device Lot Number: CHDCZ9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/12/2023
• Date Device Manufactured: 05/04/2007
• 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 Sex: Female