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

Catalog Number	H1-LS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis the hawkone-ls affiliated to this investigation was returned for evaluation.No ancillary devices, cines images or procedural notes were received.The hawkone-ls device was examined.Visual inspection of the device revealed a bulge on the distal end with the tecothane protruding with an unknown substance inside.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the hawkone 7f to treat the superficial femoral/ popliteal artery, as per ifu.It was reported the physician encountered difficulty removing the device from the 45cm destination sheath.The device was removed from the patient with no injury noted, material was observed protruding from the side wall of the nosecone.No injury to the patient reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC; 9775 toledo way; irvine; california CA
• MDR Report Key: 7056779
• Report Number: 2183870-2017-00526
• Device Sequence Number: 944311
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/23/2017

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: 11/08/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A372426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR