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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER LEGEND OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC IRELAND SPRINTER LEGEND OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number SPL12510WL
Device Problem Leak/Splash (1354)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)
Event Date 06/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Evaluation summary: the distal tip was damaged. There was no evidence of any material detachment of the balloon. During the analysis the device failed negative prep. Pressure was applied to the device and liquid was seen exiting the balloon, confirming the presence of a leak. A pin-hole leak was detected approx. 8. 5 mm from the distal tip. The leak site was jagged and uneven. A lead in scratch was evident distal to the leak site.
 
Event Description
It was reported that the physician was attempting to use a sprinter legend balloon to post-dilate a bifurcation lesion stented in the om and cx, dilating the struts of stent in cx into om. The om had 60-70% stenosis at the ostium and minimal tortuosity. The device was inspected prior to use with no issues noted. Negative prep was performed with no issues. Resistance was noted while advancing to the lesion however excessive force was not used. It is reported that an inflation pressure of 12atm was applied however the balloon never inflated as expected. The physician stated they only saw contrast being injected into the artery. It is reported that the device was pulled back and removed from the body, when the physician noticed the balloon material was no longer on the balloon catheter, it was thought that the balloon material had sheared off the balloon catheter and that the balloon material is still in the left main coronary artery. The procedure was completed. The patient was put on ecmo and is in critical condition. The patient was subsequently taken off ecmo but remained in intensive care. Review of the returned device confirmed that the balloon material has not detached.
 
Manufacturer Narrative
Medwatch form received from fda, report number mw5063401. The following additional information was contained in the report: the plastic balloon material came off the balloon and embolized to the left main coronary artery leading to hypotension and cardiac arrest. Pt was resuscitated but is critical condition. The patient is now tolerating trach mask but not tracking. Prolonged cardiac arrest and resuscitation contributing to suspect anoxic injury was divelged. Extensive and prolonged care is now expected. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSPRINTER LEGEND OTW
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key5784755
MDR Text Key49231753
Report Number9612164-2016-00666
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103095
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 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2019
Device Catalogue NumberSPL12510WL
Device Lot Number0007938879
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2016
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: 07/12/2016 Patient Sequence Number: 1
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