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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number P4052
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use the silverhawk with a 7f non-medtronic sheath and a spider fx 6mm, to treat a 150mm soft tissue lesion with 80-90% stenosis in the superficial and popliteal artery. Artery diameter 5mm. The device was inspected and prepped as per ifu with no issues noted. The vessel was not pre-dilated and no resistance was encountered. It was reported the tip of the silverhawk became damaged but did not completely detach. This occurred where the shaft meets the cutter. The physician opened a second silverhawk device. It was reported that the thumb switch was sticking and could not be pushed all the way forward. It is unknown if the cutter returned to the housing for removal of the device, but it was removed safely. The physician completed the procedure with the second device. No deformation was noted in the cutter when removed. No patient injury reported.
 
Manufacturer Narrative
Additional information: email address product analysis: two silverhawk units were returned. The second unit had a cutter driver attached. No other ancillary devices were included. During visual inspection, biological debris was observed within the lumen of the housing assembly. The cutter was positioned 0. 3cm distal the cutter window and the plunger was located approximately 0. 6cm from the cutter window. A bend to the distal assembly housing was identified approximately 0. 2cm from the cutter window. Functional testing was completed and the thumb switch was retracted with the cutter driver powered on. The cutter driver activated and the cutter driver retracted back into the cutter window as intended. The thumb switch was advanced, but stopped at 0. 3cm distal the cutter window. The silverhawk was soaked in water for approximately 24 hours and flushed using a distal flush tool from the lab. An attempt was made to advance the thumb switch but the cutter stopped at approximately 0. 3cm distal the cutter window. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSILVERHAWK ATK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8127926
MDR Text Key129451939
Report Number2183870-2018-00558
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 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2018
Device Catalogue NumberP4052
Device Lot NumberA379918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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