MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CATHETER PASSER, DISPOSABLE, 60 CM; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Model Number	48409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
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 a piece of plastic came off the handle of a catheter passer while trying to remove the handle during a case.The piece was retrieved, and there was no patient impact.
Additional Manufacturer Narrative
The returned product was returned with the handle not attached.There was a segment broken from the neck of the passer handle.It is unknown how this damage occurred.No anomalies were observed during a review of the device history record.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHETER PASSER, DISPOSABLE, 60 CM
• Common Device Name: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9216475
• Report Number: 2021898-2019-00368
• Device Sequence Number: 14100382
• Product Code: MAJ
• 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
• Report Date (Section B): 12/26/2019

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: 05/31/2023
• Device Model Number: 48409
• Device Catalogue Number: 48409
• Device Lot Number: E48472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1