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

Catalog Number 48407

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2016

Event Type  Injury  

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 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.

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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 38CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis,mn, CA 55432 ; 7635260594
• MDR Report Key: 6179165
• MDR Text Key: 62532725
• Report Number: 2021898-2016-00474
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466326
• UDI-Public: 00643169466326
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 48407
• Device Lot Number: E16643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 45