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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN IRVINE ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN IRVINE ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number TH-LS-M
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2017
Event Type  malfunction  
Event Description
The physician was attempting to use a turbohawk atherectomy device to treat a lesion in the proximal sfa. The device was prepped as per the ifu with no issues identified. The device was advanced into the proximal edge of a stent and engaged a strut. It was reported in attempting to reposition the catheter, the thumb switch was pressed forward causing the blade of the device to clamp down on the stent strut. Efforts to disconnect the stent and atherectomy device were not successful. The atherectomy device and the stent were pulled from the body as a single unit. No alleged product issue. Angiographically and pulses ascertained via doppler indicate no damage to the patient. No intervention required or patient injury reported.
 
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Brand NameATK TURBOHAWK SMOOTH
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
COVIDIEN IRVINE
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN IRVINE
9775 toledo way
irvine CA 92618
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7199015
MDR Text Key97491293
Report Number2183870-2018-00023
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberTH-LS-M
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 Received12/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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