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

Model Number SPL12515X

Device Problems Break (1069); Device Damaged Prior to Use (2284); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Event Description

Elderly female with history of hypertension and diabetes.While having an elective staged percutaneous coronary intervention to right coronary artery via radial artery access, the sprinter hub was broken in the package.When attempted to use, the inflater would not properly attach, therefore unable to inflate.Another devise was used, no known harm to patient.

• Brand Name: SPRINTER LEGEND
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10966915
• MDR Text Key: 220190238
• Report Number: 10966915
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL12515X
• Device Catalogue Number: SPL12515X
• Device Lot Number: 218648181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1