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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number LA6JR40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Thrombus (2101)
Event Date 02/07/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use a zinger guide wire in a procedure to treat a moderately tortuous, non-calcified lesion in the proximal - mid right coronary artery (rca) with 80% proximal stenosis and 99% mid stenosis. The patient had no previous anterior pci. The patient had no previous stents, or other products implanted. The patient had a critical obstruction in the right coronary vessel caused by atheroma. There was no damage noted to the device packaging. The device was removed from the packaging per ifu with no issues. The device was inspected with no issues. The device was prepped per ifu with no issues. The wire tip was not formed by the physician. The lesion was not pre-dilated. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device and excessive force was not used. It is reported that there was low support, poor steerability/poor navigability during delivery to the target lesion and deformation of the guidewire. Other devices were in use with the wire when the issue occurred, a la6jr40 launcher guide catheter, a python kit and a 6f introducer (061102a). There is no evidence about the use of an angioplastic balloon for support in the vessel. A dissection occurred in the proximal segment of the right coronary artery. The physician implanted an integrity bare metal stent (int25018x) in the dissection site. The patient experienced sub-acute thrombosis and patient death occurred on same day as the procedure. The physician reports that the incident is related to the guidewire.                                                                                                                                                                                                                                                                                                                                                                                   .
 
Manufacturer Narrative
There is no relationship between the use of the launcher device and the death of the patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
                                                                                                                                                                                                                                                                                                                                                                                 .
 
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Brand NameLAUNCHER 6F 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 Key7387389
MDR Text Key104023849
Report Number1220452-2018-00033
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K021256
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 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberLA6JR40
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 Received04/12/2018
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: 03/30/2018 Patient Sequence Number: 1
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