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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 SPL12510X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative
It was additionally reported that following further discussion with the physician it would appear that operator error may have contributed to this issue and that the device was not likely to be at fault. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician was attempting to use a sprinter legend rx balloon to treat a distal vessel lesion. No damage was noted to device packaging and no issues removing the device from the hoop/tray. The device was inspected and negative prep was performed with no issues noted. The device was not kinked and restraightened during use. The lesion was pre-dilated. It was reported that the tip of the balloon fractured during 'kissing balloon' technique. They were unable to retrieve the balloon despite attempting a number of techniques for removal including an attempt using a snare that was was unsuccessful. In the end an extra balloon was used to park the affected piece of balloon in a small vessel.
 
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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 MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7188829
MDR Text Key102621227
Report Number9612164-2018-00070
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K103095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/03/2020
Device Catalogue NumberSPL12510X
Device Lot Number213581135
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 Received02/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/18/2017
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: 01/15/2018 Patient Sequence Number: 1
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