MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	48409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2016
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.The instructions for use that accompany the device caution ¿improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.¿.
Event or Problem Description
It was reported to medtronic neurosurgery that the tip of passer broke off intraoperatively.According to the report, the tip was never found and it is unknown if the tip remains in the patient.The procedure was successfully completed using another product and there was no injury to the patient.
Additional Manufacturer Narrative
Additional information received reported the patient had congenital hydrocephalus.According to the report, the patient was undergoing placement of a left ventriculoperitoneal shunt with laparoscopic placement of the peritoneal catheter when the issue occurred.Patient information updated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6179128
• Report Number: 2021898-2016-00473
• Device Sequence Number: 10995196
• Product Code: JXG
• UDI-Device Identifier: 00643169466319
• UDI-Public: 00643169466319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K911382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/17/2016

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: 48409
• Device Lot Number: E16735
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 06/26/2017; 09/28/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 45