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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 A14BX035150170
Device Problems Burst Container or Vessel (1074); Expiration Date Error (2528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician was using a rapidcross pta balloon to treat a moderately calcified severely tortuous 60% stenotic lesion in the mid distal right posterior tibial artery. The artery diameter and lesion length were reported to be 3mm 100mm, respectively. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was prepped without issue. A 6fr non-medtronic sheath was used with no embolic protection. The device was inflated with a non-medtronic inflation device and contrast with saline solution was used as inflation fluid. The balloon burst at 6atm. It was reported that there were difficulties experienced when removing the device as resistance was felt. The balloon would not come off the guidewire thus, both were removed together along with the sheath. All balloon fragments were retrieved. The balloon was noted to have been used past its ubd. There was no patient injury 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 Key8565785
MDR Text Key143598289
Report Number2183870-2019-00197
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/24/2019
Device Catalogue NumberA14BX035150170
Device Lot NumberA216827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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