MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6F; CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Stenosis (2263); Vascular Dissection (3160); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance medtronic¿s hawkone 6f directional atherectomy system.Survey results are received for a interventional cardiologist practicing in (b)(6).The respondent has been using the hawkone 6f directional atherectomy system since 2019 and has performed a total of 200 procedures using this system.During use of the hawkone 6f directional atherectomy system the respondent reports encountering the following device related complications: arterial dissection, arterial spasm, entry site complications, restenosis of the treated segment, total occlusion of the peripheral artery events were deemed device related.The total occlusion of the peripheral artery event was reported to be very concerning.The respondent classified the arterial dissection and restenosis of the treated segment events as somewhat concerning.The arterial spasm and entry site complications events were regarded as being not at all concerning.

• Brand Name: HAWKONE 6F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9346809
• MDR Text Key: 167136053
• Report Number: 9612164-2019-04818
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other