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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 SPL12512X
Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2016
Event Type  malfunction  
Manufacturer Narrative
Product analysis:. There was a radial detachment of the balloon material. Approx. 6mm of balloon material remained on the inner shaft proximal to the detachment site. The balloon material at the detachment site was uneven. The marker band had detached from the inner shaft and was returned with the device. Approx. 7-9 mm of balloon material was not returned with the device. The inner shaft had detached proximal to the tip seal bond. The device tip was detached at the tip seal bond and did not return with the device. Approx. 3. 5- 4. 0 mm of tip did not return. Inner shaft stretched at tip seal bond for approx. 7mm. 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.
 
Event Description
The physician was attempting to use a sprinter legend rx balloon. Upon removal from the patient via the guide catheter it was noted that the (metal) tip of the device came off the end. Contrast was used to recheck the patient and no visible parts were noted as left behind. Patient disease found to be advanced and will need restorative surgery imminently ¿ unrelated to this catheter fault.
 
Manufacturer Narrative
The lesion was in an extremely calcified proximal diffused lad, with no major tortuosity. There was resistance when advancing and while pulling back the balloon. It was advised that this was due to the calcified nature of the vessel. A slow constant force was required, but nothing extraordinary during advancement. No brute force used during removal. Resistance was encountered when removing the device from the patient, due to calcified nature of the vessel. The balloon catheter was removed with some strength. The ballooning procedure of the lad was abandoned, and the patient was sent for cabg.
 
Manufacturer Narrative
Procedural image analysis: review of the procedural images confirm the difficult nature of the vessel/lesion morphology. The arching of the guidewires confirms difficulty advancing the device. The images capture what appears to be contrast leaking from the balloon. Subsequent images capture the removal of the inner shaft marker from the 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 Key5969926
MDR Text Key55431490
Report Number9612164-2016-00995
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNZ
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,Followup
Report Date 12/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2018
Device Catalogue NumberSPL12512X
Device Lot Number210428330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2015
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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