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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO LAUNCHER CATHETER, PERCUTANEOUS

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MEDTRONIC MEXICO LAUNCHER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-DAN-LAUNCHER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vascular Dissection (3160); Unspecified Tissue Injury (4559)
Event Date 06/18/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

During a procedure and attempt was made use a launcher guide catheter. It was reported that an aortic dissection was suspected at the rca ostium during use of the guide catheter. The contrast agent suddenly stopped flowing to the distal lesion on angiography and the dissection was diagnosed. The patient experienced chest pain and st elevation. Stenting was performed to treat the dissection. Cag could not be performed, and ivus was used instead to continue and complete the procedure with no adverse patient consequences. The guide catheter was at the rca ostium when the issue occurred. It is believed that the issue was due to the launcher guide catheter. The patient has been discharged from the hospital.

 
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Brand NameLAUNCHER
Type of DeviceCATHETER, 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 Key12224960
MDR Text Key263392095
Report Number9612164-2021-02879
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK132673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK-DAN-LAUNCHER
Device Catalogue NumberUNK-DAN-LAUNCHER
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 Received09/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 07/26/2021 Patient Sequence Number: 1
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