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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 A14BX040150170
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a rapidcross pta balloon with a non-medtronic 6fr sheath and 0. 014 non-medtronic wire during treatment of a 150mm cto (chronic total occlusion - 100%) in the patient¿s distal superficial femoral artery (sfa). Severe vessel calcification is reported. Artery diameter reported as 6mm. A non-medtronic (bard) inflation device was used for balloon inflation. There was no damage noted to the product packaging prior to use. No issues were noted when removing the device from the packaging. Ifu was followed and the device was prepped without issue. It is reported once the sfa cto was crossed and confirmed, the 0. 014 non-medtronic wire was placed, and the rapidcross balloon was advanced into the distal sfa at the re-entry area. The balloon was inflated 3 times in the sfa and on the 4th time a longitudinal burst at 14atm is reported. When the physician was removing balloon, resistance was felt coming into the sheath. The physician gently tugged on the catheter, but it would not move. The physician then tugged on the wire and fond the wire was stuck onto the balloon and the sheath. The physician then used a buddy wire and had to remove the whole sheath due to the balloon inside of the sheath being occlusive. The patient¿s sfa was inspected and the physician did not angiographically see any remainder of balloon. A new pta balloon was used to complete the procedure. 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 
EI  
091708734
MDR Report Key11045308
MDR Text Key222634447
Report Number2183870-2020-00447
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
Report Date 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX040150170
Device Catalogue NumberA14BX040150170
Device Lot NumberB057801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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