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

Model Number SPL15020X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Event 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8013617
• MDR Text Key: 125284415
• Report Number: 8013617
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00613994902467
• UDI-Public: (01)00613994902467(17)200926(10)214098679
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA