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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3/MEDTRONIC RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATION CATHETER 2.5MM X 40MM X 170CM

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EV3/MEDTRONIC RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATION CATHETER 2.5MM X 40MM X 170CM Back to Search Results
Model Number A14BX025040170
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 11/09/2017
Event Type  Injury  
Event Description
Wire and balloon catheter were through a 6fr sheath in right femoral artery and in to the descending aorta to perform intervention in patient's right radial artery bypass. Balloon successfully placed over the wire and deployed in radial bypass. While attempting to remove balloon from body over the wire, physician noted wire had looped in descending aorta. Physician attempted to straighten out loop in wire by sliding balloon catheter back and forth. While doing this, approximately 30 cm of the balloon catheter (with balloon attached) sheared off in to the descending aorta. Physician noted missing piece when catheter removed from patient's body. A 6fr sheath also removed and cut to try to locate missing catheter piece. Sheared piece was quickly located under fluoroscopy by locating balloon markers and successfully removed from body intact with snare device. Physician examined all equipment to ensure it had been removed entirely from body.
 
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Brand NameRAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATION CATHETER 2.5MM X 40MM X 170CM
Type of DeviceRAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATION CATHETER 2.5MM X 40MM X 170CM
Manufacturer (Section D)
EV3/MEDTRONIC
MDR Report Key7027293
MDR Text Key92142431
Report NumberMW5073268
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX025040170
Device Lot NumberA339722
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 11/13/2017 Patient Sequence Number: 1
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