MAUDE Adverse Event Report: MEDTRONIC, INC. SPRINTER LEGEND; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	SPL25015X
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of chest pain.Presented with bilateral arm pain as well as jaw pain.Went to cath lab and while testing the device, the metal stylet would not leave that balloon as usual.

• Brand Name: SPRINTER LEGEND
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10424799
• Report Number: 10424799
• Device Sequence Number: 2987099
• Product Code: LOX
• UDI-Device Identifier: 00613994902597
• UDI-Public: (01)00613994902597(17)230213(10)219512061
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/12/2020
• Report Date (Section F): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SPL25015X
• Device Lot Number: 219512061
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 89
• Date Report Sent to FDA: 08/12/2020