• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC, INC LAUNCHER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-DAN-LAUNCHER
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 06/20/2020
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 tortuosity, moderate calcified lesion exhibiting 90% stenosis in the mid circumflex (cx) artery. There was no damage noted to the packaging. The device was removed from packaging per ifu with no issues. The device was inspected with no issues. The device was prepped per ifu with no issues. Resistance was not encountered. Excessive force was not used during delivery. It was reported that the soft tip got dislodged during delivery to the lesion. The soft tip was cut down and pulled back and removed from the patient. The patient is alive with no injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLAUNCHER
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 Key10243701
MDR Text Key197917953
Report Number1220452-2020-00055
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,Followup
Report Date 10/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL 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 Received10/07/2020
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

Patient TREATMENT DATA
Date Received: 07/08/2020 Patient Sequence Number: 1
-
-