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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number P4044
Device Problems Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use a silverhawk btk atherectomy device with a 6fr non-medtronic sheath and 0. 014 non-medtronic guidewire during treatment of an 80mm soft tissue cto (chronic total occlusion-100%) in the patient¿s mid right popliteal artery. Slight vessel calcification is reported. Artery diameter reported as 4mm. Ifu was followed. The vessel was not pre-dilated. It is reported that after running the device and pulled out of the body, a black string like substance was encountered coming out of the cutter window. The observed material appeared to be fibrous. Unclear if this was part of the device. The device was not wiped down between insertions. The cutter was inside housing when removed. When removed from patients, all parts of device were accounted for. The device was removed safely. A replacement hawk one device was opened to complete the procedure. No patient injury reported.
 
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Brand NameSILVERHAWK BTK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11929667
MDR Text Key254041660
Report Number9612164-2021-02162
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 07/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP4044
Device Catalogue NumberP4044
Device Lot Number0010468763
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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