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

Model Number	SPL15020X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon placed in left anterior descending coronary artery.Doctor inflated balloon.Balloon burst in artery.Balloon marker visualized under fluoroscopy in septal perforator coronary artery.

• Brand Name: SPRINTER® LEGEND
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8013617
• Report Number: 8013617
• Device Sequence Number: 13798497
• Product Code: LOX
• UDI-Device Identifier: 00613994902467
• UDI-Public: (01)00613994902467(17)200926(10)214098679
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/22/2018
• Report Date (Section F): 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPL15020X
• Device Catalogue Number: SPL15020X
• Device Lot Number: 214098679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/22/2018