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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
Model Number A14BX025210170
Device Problems Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 08/11/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a rapidcross pta balloon along with non-medtronic 7fr sheath, guide wire and embolic protection during procedure to treat a little calcified plaque in the proximal, mid and distal posterior tibial artery (pta) with 80% stenosis. The vessel was little tortuous. The vessel diameter and lesion length are 2. 5mm and 100mm respectively. The device was prepped per ifu with no issues identified. It was reported that while removing the balloon after inflation, break/fracture occurred at the luer/hub. It was reported that removal difficulties occurred, there was difficulty removing balloon following balloon inflation and a non-medtronic snare device was used to remove detached balloon. After balloon was removed physician stunted the iliac and finished the procedure. There was no further 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 Key10418809
MDR Text Key203332496
Report Number2183870-2020-00250
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,Followup,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/07/2021
Device Model NumberA14BX025210170
Device Catalogue NumberA14BX025210170
Device Lot NumberA737051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2018
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: 08/18/2020 Patient Sequence Number: 1
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