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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aneurysm (1708)
Event Date 04/14/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A sprinter legend balloon catheter was used to pre-dilate a non-tortuous, non-calcified lesion in the mid om. There was no damage noted to the device packaging. There were no issues when removing the device from the hoop/tray. The device was inspected with no issues. (b)(6) prep was performed with no issues. The lesion was pre-dilated. The device did not pass through a previously deployed st ent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It is reported that as the physician inflated the balloon they noticed an aneurysm had developed proximal to the lesion. It is unknown if the balloon was the cause. The patient is reported as being alive without injury.
 
Manufacturer Narrative
Image review: cine image provided by the account, capturing the inflation of an unknown device. There appears to be a ¿bulge¿ proximal to the inflated balloon. Contrast is not visible being injected into the vessel from the still cine image provided therefore a vessel aneurysm cannot be confirmed. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7513478
MDR Text Key108226519
Report Number9612164-2018-01073
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 09/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/14/2020
Device Catalogue NumberSPL12510X
Device Lot Number213509448
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 Received09/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/19/2017
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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