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

Catalog Number SPL25015X

Device Problem Deflation Problem (1149)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The physician intended to use 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.It was reported that the physician felt the stylet was hard to remove and required more force than normal.The target lesion was a mid lesion in an artery with moderate tortuosity and a little calcification.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The sprinter legend device passed through a previously deployed stent.It was reported that the balloon was inflated however it would not deflate during the stemi case.The physician over inflated the balloon within the stent to burst the balloon in order to deflate it and remove it from the patient.No patient injury reported.

Manufacturer Narrative

Patient presented with chest pain, elevated troponins consistent with acs.It was reported that on first attempt the balloon would not inflate in the stent.On another attempt the balloon was inflated, however it would not deflate.The catheter position was in a previously placed stent so the catheter was over inflated and ruptured.The balloon was removed intact.Post picture of the site revealed no leakage or dissection.Report # mw5059314.

• 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: 5410550
• MDR Text Key: 37480727
• Report Number: 9612164-2016-00105
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790017
• 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,Followup
• Report Date: 02/12/2016

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: 06/15/2018
• Device Catalogue Number: SPL25015X
• Device Lot Number: 209729751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Date Device Manufactured: 06/16/2015
• 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