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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3, INC. EV3 EVER-CROSS BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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EV3, INC. EV3 EVER-CROSS BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W06030135
Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 09/02/2021
Event Type  Injury  
Event Description
During a routine outpatient peripheral angiogram, the patient was found to have tortuous, stenosed, heavily calcified illacs. The physician dilated the vessel with a ev3 ever cross 6 x 30 balloon. Upon inflation the balloon ruptured. The physician tried to remove the rupture balloon over the wire but the edges prevented him from pulling the balloon out through the sheath. The patient was transferred to the operating room where a surgeon successfully removed the dislodged device and patient was transferred to the icu for recovery. Fda safety report id # (b)(4).
 
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Brand NameEV3 EVER-CROSS BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
EV3, INC.
MDR Report Key12480855
MDR Text Key272137598
Report NumberMW5103978
Device Sequence Number1
Product Code LIT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAB35W06030135
Device Lot NumberB006908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
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