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

Catalog Number SPL12506X

Device Problems Break (1069); Burst Container or Vessel (1074); Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: there was a detachment on the hypotube 112.9cm proximal to the hypotube bond.The detachment site was oval and jagged.The luer and strain relief were not returned for analysis.There was a kink on the hypotube 36.9cm proximal to the hypotube bond.There was a radial detachment of the balloon material.The inner shaft was stretched, kinked and bunched distal to the inner shaft marker.The balloon material was uneven at both sides of the detachment site.The distal tip was stretched and deformed.(b)(4).

Event Description

It was reported that the physician was attempting to use one sprinter legend to treat a severely calcified and moderately tortuous lad lesion (2.5 x 15 mm), exhibiting 99% stenosis.The device was removed from its packaging and inspected with no issues noted.Negative prep was performed with no issues noted.The device did not pass through a previously deployed stent.The lesion was not pre-dilated.It was reported that as the device was crossing the lesion, the tip of the device became trapped and the physician was unable to retract the device.The balloon was inflated to 16atm for 10 sec.As the physician removed the device by force, the tip of the balloon was partially torn off.The physician did not attempt to remove the fragment from the patient.The physician is querying how much of the device remains in the patient.No further patient injury was 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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5952077
• MDR Text Key: 54750290
• Report Number: 9612164-2016-00970
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2019
• Device Catalogue Number: SPL12506X
• Device Lot Number: 210907840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Date Device Manufactured: 03/03/2016
• 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