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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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MEDTRONIC, INC. ACHIEVE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Event Type  Death  
Event Description
The procedure was cryo af(atrial fibrillation).Typical protocols were performed (general anesthesia, mapping, phrenic pacing, etc.).Case was mapped with ensite x, navx mode.The catheters in the body: innovative health reprocessed dynamic xt deca, innovative health reprocessed achieve catheter, flexcath, articfront balloon, and sterilmed acunav ice.Transeptal puncture was done with the flexcath cross and the flex cath sheath.All pulmonary veins were isolated via freezing with cryo balloon.No intraoperative complications were observed.Immediately post-operation, patient was hypotensive and hypoxic.Attempts at resuscitation were performed by hospital personnel, but were not successful.No fault has been attributed to any abbott products or to any products used during the case.Only abbott product involved in the case were ensite x patches.Reference reports: mw5153775, mw5153776, mw5153777, mw5153779, mw5153780.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
ACHIEVE CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key19096418
MDR Text Key340263237
Report NumberMW5153778
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/11/2024
Patient Sequence Number1
Treatment
ACUNAV ICE CATHETER; ARCTICFRONT BALLOON; CRYOBALLOON ; ENSITE X PATCHES; FLEXCATH; FLEXCROSS
Patient Outcome(s) Death;
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