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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number TH-LX-M
Device Problems Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2019
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 the turbohawk to treat a soft tissue lesion with 90% stenosis in the left mid, distal superficial femoral artery as per ifu. It was reported during the third re-entry into the patient the physician encountered difficulty closing the device. The turbohawk was removed and flushed as per ifu. Mixed in with the removed plaque was a small piece of clear plastic. The device functioned properly at that point but was not reintroduced into the patient. The procedure was completed using dcb with no issues noted. No patient injury reported.
 
Manufacturer Narrative
Photo analysis: the photo provided by the customer has been analyzed. The unknown material was inspected and showed characteristics similar to pet from within the housing of the distal assembly of the turbohawk. Device evaluation: the turbohawk was returned with a detached cutter driver and a folded piece of blue cloth. No other ancillary devices were included. The turbohawk was removed from the bag and inspected. It was observed the cutter was approximately 0. 5 cm advanced distal the cutter window. No external damages to the turbohawk was noted. The blue piece of cloth was unfolded and found a rectangular piece of clear material. The material was and showed similar characteristics to pet from within the id of the housing assembly. The length and height was approximately 0. 3 cm. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameATK TURBOHAWK SMOOTH
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8239896
MDR Text Key132801157
Report Number9612164-2019-00165
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2021
Device Catalogue NumberTH-LX-M
Device Lot Number0009306243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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