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

Catalog Number SPL12515X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: there was a portion of the balloon material and inner shaft marker band detached.There was approximately 6.5mm of the balloon material left.The detachment site on the balloon material was jagged and damaged.The tip material of the inner section of the distal shaft was severely stretched and deformed.The hypotube was kinked 2cm distal to the strain relief.The transition shaft was kinked at the guide wire entry port.The distal shaft was kinked at 2cm, 2.5cm and 3.1cm distal to the guide wire entry port.(b)(4).

Event Description

The physician used a sprinter legend balloon during a procedure.The device was inspected prior to use with no issues noted.The physician advanced the sprinter legend through a highly tortuous om exhibiting 99% stenosis and calcification, but when an attempt was made to retract the balloon it broke off and went down the om.The lesion was not pre-dilated with another device prior to the advancement of the sprinter legend.It was reported that no resistance was noted during delivery of the device to the lesion site.The balloon had been inflated and sufficient time was given to allow the balloon to deflate prior to attempting to remove the device from the patient.After an attempted snare the detached portion of the device was not removed from the patient, it travelled to the distal section of the om into a small branch.No patient injury 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: 5409916
• MDR Text Key: 37446952
• Report Number: 9612164-2016-00104
• 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: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2018
• Device Catalogue Number: SPL12515X
• Device Lot Number: 209600024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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
• Patient Outcome(s): Required Intervention