MAUDE Adverse Event Report: MEDTRONIC IRELAND CUTTERDRIVER; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-14550
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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
It was reported that the physician used a hawkone h1-m device with a non-medtronic 6fr sheath and a 4.0mm spider fx embolic protection device to treat a 20mm severely calcified cto (chronic total occlusion-100%) in the patient¿s distal right popliteal artery of 5mm diameter.Slight tortuosity was reported.The ifu was followed and the device was prepped without issue.The vessel was pre-dilated.No resistance was felt during advancement.The device stopped packing after a couple of passes.The physician removed it to clean but it would only advance about one third of the way after cleaning.It was reported to have been flushed multiple times with no visible tissue observed but the cutter would not pack more than one third of the way.The device was replaced with a new hawkone h1-m to complete the atherectomy followed by a 5x40 chocolate pta balloon and a 5x40 inpact admiral.No patient injury was reported.
Additional Manufacturer Narrative
Additional information the cutter remained inside the housing during withdrawal from the patient.The device was safely removed from the patient with no obvious damage to the cutter.The blade returned into the housing during withdrawal from the patient if information is provided in the future, a supplemental report will be issued.

• Brand Name: CUTTERDRIVER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8627844
• Report Number: 9612164-2019-01866
• Device Sequence Number: 1968802
• Product Code: MCW
• UDI-Device Identifier: 00643169968554
• UDI-Public: 00643169968554
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2019

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: 01/16/2022
• Device Catalogue Number: H1-14550
• Device Lot Number: 0009543587
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR