MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM VENTRICULAR CATH; STANDARD CATHETERS

Catalog Number	823041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	08/06/2023
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 2 of 2 reports linked to mfg report numbers: 3013886523-2023-00280.A physician reported a certas valve (id 828814) and hakim ventricular catheter (id 823041) were implanted via ventricular peritoneal shunt on (b)(6), 2023 with setting 3.The patient visited the hospital on (b)(6) with recurrence of symptoms.On (b)(6) 2023, ventricular enlargement was confirmed by x-ray examination.The chamber could not be pushed, and the flow had stopped.Due to suspicion of obstruction, the valve and catheter were removed and replaced on (b)(6), 2023.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The ventricular catheter (id 823041) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were found.The catheter was irrigated; no occlusions noted.The complaint is unconfirmed.Root cause - no root cause for the issue reported by the customer could be determined as no defects could be found with the catheter.However, 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.As seen in the investigation no occlusion was found with the catheter.

• Brand Name: HAKIM VENTRICULAR CATH
• Common Device Name: STANDARD CATHETERS
• 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: 17596608
• Report Number: 3013886523-2023-00281
• Device Sequence Number: 7570621
• Product Code: JXG
• UDI-Device Identifier: 10381780518815
• UDI-Public: 10381780518815
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• 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): 10/13/2023

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: 823041
• 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: 08/06/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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: 10 YR
• Patient Sex: Female