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U.S. Department of Health and Human Services

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

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COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number A14BX020150170
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
Physician was attempting to use a rapidcross pta balloon during procedure to treat a moderately calcified plaque lesion in the mid a nterior tibial artery (ata). The vessel was little tortuous. No embolic protection was used. A non-medtronic inflation device was used for balloon inflation. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. Balloon deflation difficulties was reported with device not able to deflate at lesion site. The deflation issue was noted following the first inflation. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It was reported that physician was unable to deflate balloon even pulling negative with inflation device and syringe. Physician was forced to pull out the balloon while it was still inflated at 6atm. No vessel damage occurred. There was no patient symptoms or complications associated with this event. There was no patient injury reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRAPIDCROSS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14111361
MDR Text Key289271841
Report Number2183870-2022-00138
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX020150170
Device Catalogue NumberA14BX020150170
Device Lot NumberB320808
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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