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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
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of the launcher guide catheter. Survey results are from an interventional cardiologist in practice for 27 years. In a two-month period the physician has used 6f and 7f launcher guide catheters 100 times. The following complications were encountered. 5 hematomas related to the procedure but not directly to the device itself. 1 foreign material encountered during the procedure. 5 unsuccessful attempts to use the launcher during a coronary procedure as the catheter did not reach the lesion. 5 unsuccessful attempts to use the launcher during a peripheral procedure due to no support.
 
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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 
EI  
091708734
MDR Report Key12511520
MDR Text Key272650018
Report Number1220452-2021-00056
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
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

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