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

Catalog Number SPL20015X

Device Problems Stretched (1601); Device Operates Differently Than Expected (2913); Material Deformation (2976); Moisture or Humidity Problem (2986); Scratched Material (3020); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2014

Event Type  malfunction  

Event Description

It was intended to use a sprinter legend 2.00 x 15 mm balloon dilation catheter to pre-dilate a calcified and stenosed lad lesion.During use it is reported that the device could not pass the lesion.The physician used a new device to complete the surgery.The device had been prepped before use with no issues reported.The procedure was completed with a 1.5 x 15 mm balloon.No reported patient complications.The device was returned to the manufacturing facility and through analysis, the device was observed to be damaged.Evaluation summary: the device was returned for analysis.The balloon material was bunched and deformed.The inner shaft was stretched and bunched.Hardened contrast was present inside the inflation lumen and balloon.The device was placed in a 37 degree celsius waterbath for 24 hours to disperse the hardened blood and contrast in order to facilitate balloon inflation.The device failed negative prep.Pressure was applied to the device and liquid was seen exiting the balloon.A small radial tear was located on the balloon working length over the distal marker band.A scratch was present on the balloon just proximal to the tear.

Manufacturer Narrative

Evaluation results: patient¿s condition affected effectiveness of device (lesion morphology - calcification in vessel.The balloon was scratched and torn indicating calcification may have contributed to the balloon tear).Deformation problem (balloon tear).Evaluation conclusions: device failure related to patient condition (lesion morphology - calcification in vessel.The balloon was scratched and torn indicating calcification may have contributed to the balloon tear).(b)(4).

• 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 2257 0; 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: 4192441
• MDR Text Key: 5157589
• Report Number: 9612164-2014-01356
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2017
• Device Catalogue Number: SPL20015X
• Device Lot Number: 208224138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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 Age: 00045 YR