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

Model Number SPL12506X

Device Problems Break (1069); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

During cardiac catheter procedure balloon catheter was inserted through guide catheter and advanced into the lesion, inflated and ruptured and broke off in lesion, multiple attempts made to remove balloon by physicians ultimately resulting in distal embolization of balloon fragment.A decision was made to leave in place by the team.

• Brand Name: SPRINTER® LEGEND
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 6577759
• MDR Text Key: 75517193
• Report Number: 6577759
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2017,05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SPL12506X
• Device Catalogue Number: SPL12506X
• Device Lot Number: 210065458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR