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

Catalog Number	H1-LS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cine image analysis summary: the hawkone directional atherectomy device was not received for evaluation.No ancillary devices from the procedure were received.A single cine image was received for evaluation.The single cine image is of a contrast flow through a vessel.The radiopaque marker band of a support catheter and a guidewire are visible in the cine image.The vessel exhibits signs of a pseudo aneurysm.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 device for treatment of a 10mm very calcified non-cto lesion in the proximal right common iliac artery.The diameter was noted as 8-9mm.The vessel was reported to be moderately tortuous.The device was prepped as per ifu without any issue.The procedure was carried out successfully.It was reported, 2 weeks post procedure, in a follow-up visit, that a pseudo aneurysm was detected via ultrasound.Patient was brought back for a non-mdt covered stent.The patient is reported to be doing well.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7525124
• Report Number: 2183870-2018-00282
• Device Sequence Number: 1696644
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A334854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention