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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 A14BX020210170
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Physician was using a rapidcross pta balloon along with non medtronic 6fr sheath and guide wire during procedure to treat a mildly calcified soft tissue in the left mid common iliac artery. The device was prepped per ifu. The vessel is mildly tortuous. The device/component cracked, detached/fractured during delivery through the vessel. The catheter deformed at the shaft, stretching, twisting and bunching. The puncture site was increased, snare was inserted and the device was retracted by force. Resistance was encountered when advancing the device. Excessive force was used when the product was removed. It was confirmed the exit port of the wire broken. There was patient injury reported, heamorrhage/bleed at access site and was treated with compression hemostasis.

 
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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 Key10068666
MDR Text Key191383259
Report Number2183870-2020-00146
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK130911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberA14BX020210170
Device LOT NumberA919480
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/23/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/19/2020 Patient Sequence Number: 1
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