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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 A14BX020020170
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use a rapidcross to treat a 150mm soft tissue lesion with 90% stenosis in the left proximal anterior tibial artery, diameter of artery 2mm. A 4/5 slender terumo medical sheath and a 0. 014 lake region medical guidewire was used. There was no damage to the packaging or to the device when removing from hoop/tray. The device was prepped with no issues. No embolic protection was used. The device passed through a previously deployed stent. No resistance was encountered during advancement of the device and no excessive force used. It was reported that wire movement issues occurred, and the guidewire locked up during the procedure. The physician pulled the guidewire lumen with resistance and was unable to remove the device from the guidewire. The wire was removed from the patient and a pressure dressing applied. The rapidcross was inflated to 8atms with a boston scientific inflation device using 1:1 contrast/saline. The balloon detached during removal from the patient while pulling the device out of the sheath. When the catheter was removed the physician noticed that the balloon catheter segment was not attached. X-ray fluoroscopy located the radio opaque markers and identified the balloon with some wire at the level of the left auxiliary artery near the subclavian. As the physician attempted to recover the detached segment the patient coded and was transferred to the emergency room at another facility. The detached portion remains in the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: a cut down surgical procedure was conducted. The detached portion of the balloon was removed from the patient. The patient is reported as stable and has been discharged from hospital. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8331512
MDR Text Key135884351
Report Number2183870-2019-00069
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 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2020
Device Catalogue NumberA14BX020020170
Device Lot NumberA480801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/23/2017
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: 02/12/2019 Patient Sequence Number: 1
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