MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	H1-LX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a hawkone atherectomy device with a 7fr sheath and 0.014 guidewire during treatment of a calcified lesion in the patient¿s proximal left superficial femoral artery (sfa).Moderate vessel calcification is reported.Pre-dilation was performed.Tip damage is reported.The nosecone is reported as damaged.No separation occurred at the hinge pin.The device was used to treat the patient before tip damage was noted.No components detached.It is unknown if any chips were missing from the cutter.The device was removed from the patient without issue.It is unknown the position of the cutter during device removal from the patient.There was no vessel damage noted.The procedure was ended with removal of the arterial sheath intact with the site sealed with manual compression, there was no further patient treatment required.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the device was returned within a sealed biohazard, plastic bag.Within the bag, the hawkone was loosely contained within a non-sterile, sealed pouch, and another plastic biohazard bag.A device label sticker was adhered to the outside of the plastic bag which indicated lot number 0010052379, consistent with the reported device.The cutter driver was not returned with the device.No other ancillary devices were received.Biological debris was noted throughout.The housing was observed to be bent into an ¿s¿ shape.The proximal end of the guidewire lumen (gwl) was disengaged, approximately 4.5cm distal to the cutter window.The cutter was advanced approx.2.5cm distal to cutter window.A slight bulge was noted in the housing at location of the cutter.Microscopic inspection revealed the housing gwl had zipper tearing.Biological debris was noted on the rotating distal tip, the biological debris was removed and disengagement of the tip gwl was noted (proximal end).It appeared like the gwl was pulled distally.Inspection of the housing bulge revealed biological debris was distal to the cutter.The inner laser drilled coils were damaged.No tearing of tecothane was noted.The device was connected to a known good cutter driver.An attempt was made to retract the cutter unsuccessfully because the cutter was caught by the inner laser drilled coils.No damage was noted to the cutter window.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10184294
• Report Number: 9612164-2020-02298
• Device Sequence Number: 16370844
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0010052379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/13/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR