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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number LAUNCHER
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

A 6f launcher guide catheter was used during a procedure to treat a moderate calcified, non tortuosity lesion exhibiting 99% stenosis in the mid left anterior descending (lad) artery. There was no damage noted to the packaging. The device was removed from packaging per ifu. The device was inspected with no issues. The device was prepped per ifu with no issues. Resistance was not encountered when advancing the device and excessive force was not use during delivery. It was reported that the soft tip of the 6fr launcher dislodged and the an inflated balloon was used to keep the tip in the radial artery. The patient is alive with no injury.

 
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Brand NameLAUNCHER UNK GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10313719
MDR Text Key200042731
Report Number1220452-2020-00063
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK132673
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 08/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLAUNCHER
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 Received08/07/2020
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: 07/23/2020 Patient Sequence Number: 1
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