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

Catalog Number H1-S

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

Medwatch report#: mw5108781.If information is provided in the future, a supplemental report will be issued.

Event Description

A physician reported that during use of the hawkone m atherectomy device for a peripheral arteriography procedure, the device jammed and failed to function.The device was replaced with a hawkone s atherectomy device which was advanced through the recommended 6fr sheath.Resistance was noted during advancement and retrieval of the device.The crown is reported to have become dislodged in the sheath within the patient.The sheath was removed, and the crown was retrieved.It is reported intervention was required.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14520750
• MDR Text Key: 292795528
• Report Number: 9612164-2022-02026
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2022
• 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): Required Intervention