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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
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.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, 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 Key5410550
MDR Text Key37480727
Report Number9612164-2016-00105
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received02/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/15/2018
Device Catalogue NumberSPL25015X
Device Lot Number209729751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/04/2016 Patient Sequence Number: 1
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