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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 SPL12506X
Device Problems Break (1069); Burst Container or Vessel (1074); Difficult To Position (1467); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/17/2016
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: there was a detachment on the hypotube 112. 9cm proximal to the hypotube bond. The detachment site was oval and jagged. The luer and strain relief were not returned for analysis. There was a kink on the hypotube 36. 9cm proximal to the hypotube bond. There was a radial detachment of the balloon material. The inner shaft was stretched, kinked and bunched distal to the inner shaft marker. The balloon material was uneven at both sides of the detachment site. The distal tip was stretched and deformed. (b)(4).
 
Event Description
It was reported that the physician was attempting to use one sprinter legend to treat a severely calcified and moderately tortuous lad lesion (2. 5 x 15 mm), exhibiting 99% stenosis. The device was removed from its packaging and inspected with no issues noted. Negative prep was performed with no issues noted. The device did not pass through a previously deployed stent. The lesion was not pre-dilated. It was reported that as the device was crossing the lesion, the tip of the device became trapped and the physician was unable to retract the device. The balloon was inflated to 16atm for 10 sec. As the physician removed the device by force, the tip of the balloon was partially torn off. The physician did not attempt to remove the fragment from the patient. The physician is querying how much of the device remains in the patient. No further patient injury was reported.
 
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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 Key5952077
MDR Text Key54750290
Report Number9612164-2016-00970
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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 08/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2019
Device Catalogue NumberSPL12506X
Device Lot Number210907840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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