MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 38CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	48407
Medical Device Problem Codes	Break (1069); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the back end of the passer broke off intraoperatively.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.If information is provided in the future, a supplemental report will be issued.
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.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, 38CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6179165
• Report Number: 2021898-2016-00474
• Device Sequence Number: 993520
• Product Code: JXG
• UDI-Device Identifier: 00643169466326
• UDI-Public: 00643169466326
• 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,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: 48407
• Device Lot Number: E16643
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 04/28/2017; 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 45