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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 SPL25015X
Device Problem Deflation Problem (1149)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 12/30/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one sprinter legend ptca balloon catheter to treat a lesion. The device was inspected with no issues noted. It was reported that balloon deflation difficulties occurred, the device would not deflate at the lesion. Negative pressure was applied with the indeflator but the balloon failed to deflate. Negative pressure was then attempted using a 30cc syringe but was unsuccessful. The patient is alive with no injury.
 
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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 
EI  
091708734
MDR Report Key11130462
MDR Text Key225483907
Report Number9612164-2021-00062
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P790017
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 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSPL25015X
Device Lot Number0221020333
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2020
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: 01/07/2021 Patient Sequence Number: 1
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