MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	41101
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was a catheter obstruction.It was stated that the first time they tested the catheter intra-operatively, it wouldn't work.The assistant probably tried two or three times before the water came out.The catheter was placed in the ventricle, but there was no cerebrospinal fluid outflow.There was no problem after replacing the catheter.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The ventricular catheter was returned in two segments.Due to this damage, the catheter could not be tested for patency and leakage.Water was flushed through both segments of the catheter with no obstruction.Therefore, the nature of the complaint could not be replicated by the laboratory personnel.The catheter met the requirement for tensile testing.Due to the length of the catheter that was returned, only one tensile test could be performed.Therefore, the standard deviation of the tensile strength and ultimate elongation could not be calculated.There is damage to one end of both returned segments.It is unknown how this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity, and necessitate premature surgical revision of the shunt system.¿ all catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8378558
• Report Number: 2021898-2019-00073
• Device Sequence Number: 16191082
• Product Code: JXG
• UDI-Device Identifier: 00643169466500
• UDI-Public: 00643169466500
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K792007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 41101
• Device Catalogue Number: 41101
• Device Lot Number: E44490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1