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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 A14BX020150170
Device Problems Kinked; Retraction Problem
Event Date 01/04/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluation summary: the rapidcross pta rapid exchange balloon dilatation catheter was received for evaluation. Cine images from the procedure were also received for evaluation. All components of the rapidcross dilatation catheter are accounted for. Returned with the rapidcross dilatation catheter were a introducer sheath and 0. 014¿ guidewire. The distal end of introducer sheath exhibited lateral compression. The distal edge of the sheath exhibited a pitcher mouth. The proximal segment of the rapidcross dilatation catheter was tightly coiled together. Curves/bends in the catheter were noted in the catheter. The distal end of the rapidcross fracture face exhibited tensile and torsional stretching. The fracture face is located at the proximal end of the primary wire exit port. The proximal segment fracture face was approximately 135 cm distal of the manifold strain relief. The proximal segment support wire ended approximately 145 cm distal of the manifold strain relief. The distal segment of the rapidcross dilatation catheter remained on the 0. 014¿ guidewire. The guidewire exhibited a kink. The proximal end of the distal segment exhibits ¿zippering¿ of the guidewire lumen. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The physician was attempting to use a rapidcross pta balloon to treat a moderately tortuous and moderately calcified mid common iliac artery lesion. The device was removed from its packaging and inspected with no issues noted. The ifu was followed during the procedure. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. It was reported that the physician experienced difficulty removing the balloon through the sheath following balloon inflation. The balloon came off the catheter and was stuck on the guidewire. The physician was able to successfully remove the device from the patient but commented that excessive force was used. The physician felt that the non-mdt guidewire may have kinked causing the balloon to get stuck, and the non-mdt sheath was also bent at the distal tip. 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 Key7239236
Report Number2183870-2018-00059
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/18/2018
Device Catalogue NumberA14BX020150170
Device LOT NumberA149535
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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