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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 A14BX040040170
Device Problem Device Dislodged or Dislocated
Event Date 03/04/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that a physician was attempting to use a rapidcross dilation balloon to treat a lesion in the prox peroneal artery with severe calcification and 80% stenosis in a patient. A non-medtronic (viper wire) was used. No damage noted to packaging, i. E. Shelf carton, hoop/tray, no issues noted when removing the device from the hoop/tray, device was prepped per the ifu with no issues noted. It was reported that device or component detached, cracked, or fractured occurred; the device detached at hub of sheath upon removal. Small portion was hanging out of the sheath, so the physician was able to grab and remove it. Device did not pass through a previously-deployed stent, resistance was not encountered when advancing the device, excessive force was not used. No patient injury reported for this event.

 
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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 Key8393992
Report Number2183870-2019-00118
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/08/2019
Device Catalogue NumberA14BX040040170
Device LOT NumberA307191
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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