MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number SPL12506X

Device Problem Deflation Problem (1149)

Patient Problem Intimal Dissection (1333)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The physician was using a sprinter legend balloon.The device was removed from packaging per ifu and inspected with no issues noted.Negative prep was performed with no issues identified.The target lesion had severe tortuosity and severe calcification.It was reported that difficulties were experienced while removing the device prior to stent deployment/balloon inflation.Bunching was experienced at the tip.It was reported that the balloon tip deformed inside the patient and there were major problems deflating the balloon.Vessel damage/injury was reported.No further patient complications were reported.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5356747
• MDR Text Key: 35531373
• Report Number: 9612164-2016-00035
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPL12506X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1