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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN (IRVINE) SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number P4034
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Occlusion (1984)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician used a silverhawk device to treat a cto (chronic total occlusion) in a severely calcified and tortuous distal common iliac artery. The device was inspected prior to use with no issues noted. Ifu was followed and no issues were identified. It was reported that the nosecone broke off from the tip of the device in the superficial femoral artery leading to vessel occlusion. Patient was sent to surgery to remove the silverhawk nosecone.
 
Manufacturer Narrative
Resistance was encountered when advancing the device through calcified plaque. Detachment occurred during removal of the device from the patient. The cutter window was closed when attempting to remove the device. Physician attempted to pin the nosecone up against the arterial wall using a stent unsuccessfully. Stent was also removed during surgery. Patient recovering from surgery. Device evaluation: the silverhawk was inspected and it was observed the flush port was cracked and pointed in a proximal direction. The distal end of the silverhawk was inspected and observed the distal end was separated. The separation occurred distal the cutter window. The cutter housing remained intact. The clear distal tip separated from the housing. The distal tip was not returned. The gw tubing of the torque shaft showed a zipper tear throughout the segment. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSILVERHAWK BTK
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 Key8124222
MDR Text Key129032257
Report Number2183870-2018-00555
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,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/11/2019
Device Catalogue NumberP4034
Device Lot NumberA226960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2016
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: 12/03/2018 Patient Sequence Number: 1
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