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

Catalog Number	41207
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that upon opening the sterile box, the doctor realized that the catheter was longer than usual, and it ended at the middle of the ring of the stylet.According to the report, the doctor washed the surface and tried to remove the stylet, but the action was difficult to perform.Reportedly, the catheter was never implanted and was replaced with another catheter.There was no patient impact.
Additional Manufacturer Narrative
Approximately 18 cm of the catheter was returned.The returned catheter was patent and met the requirements for leak testing.The distal end of the catheter appears to be jagged.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ a review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICULAR CATHETER, SMALL, 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: 6549356
• Report Number: 2021898-2017-00259
• Device Sequence Number: 16392555
• Product Code: JXG
• UDI-Device Identifier: 00643169472716
• UDI-Public: 00643169472716
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K792007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2017

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: 07/31/2021
• Device Catalogue Number: 41207
• Device Lot Number: E16258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; 05/19/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 06/16/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 30