MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CATHETER PASSER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8591-38
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
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
On (b)(6) 2019, information was received from an healthcare professional (hcp) via a manufacturer representative (rep), regarding a catheter passer (8591-38).During the procedure, the tunneling obturator broke while the physician was reshaping the catheter passer.A new passer was opened and used.No patient impact reported.The issue was resolved.
Additional Manufacturer Narrative
Analysis of the obturator identified it was broken.The previously reported conclusion code no longer applies to this event and has been updated.The previously reported method code no longer applies to this event and has been updated.The previously reported results code no longer applies to this event and has been updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHETER PASSER
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8664450
• Report Number: 2021898-2019-00222
• Device Sequence Number: 16665764
• Product Code: LKK
• UDI-Device Identifier: 00673978226842
• UDI-Public: 00673978226842
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 01/31/2024
• Device Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: E65031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1