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

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone device with a spider fx for treatment of the patient¿s superficial femoral artery (sfa).Ifu was followed.It is reported a plastic piece was found in around the cutter window.This was noted during prep.The device was used for patient treatment without incident.The physician felt that the plaque removed could not be packed into the nose cone, but instead was falling into the spider which was noted to be fill of debris after removal more than usual because the plastic piece was encumbering the entrance into the nose cone.The procedure completed without issue.No injury to the patient reported.

• Brand Name: HAWKONE
• 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: 8645149
• MDR Text Key: 146243007
• Report Number: 9612164-2019-02015
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2019
• 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