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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number A14BX025040170
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A rapidcross pta balloon dilatation catheter was used with a. 014 x 300 non-medtronic guidewire and a 6fr x 90 cm non-medtronic sheath in the right femoral artery and descending aorta to perform an intervention in a patient¿s right radial artery bypass. The balloon was successfully placed over the wire and deployed in the radial bypass. During the removal of the balloon over the wire, it was noted the wire had looped into the descending aorta. An attempt was made to straighten out the loop in the wire by sliding the balloon catheter back and forth. When the catheter was removed, it was found that approximately 30 cm of the balloon catheter with the balloon attached sheared off into the descending aorta. The 6 fr sheath was removed and cut to try and located the missing catheter piece. The sheared piece was located under fluoroscopy by locating the balloon markers and removed with a non-medtronic snare device. The physician examined all equipment to ensure it had been removed entirely from the body. No patient injury was reported.
 
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Brand NameRAPIDCROSS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7166535
MDR Text Key101670116
Report Number2183870-2018-00006
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/07/2019
Device Catalogue NumberA14BX025040170
Device Lot NumberA339722
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/07/2016
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: 01/04/2018 Patient Sequence Number: 1
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