MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC HAWKONE M AND S DEVICES; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-M

Device Problems Break (1069); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/31/2022

Event Type  Injury  

Event Description

This is regarding malfunction of medtronic hawk s and hawk m atherectomy devices used during peripheral arteriography in this patient.Hawk m device "jammed", and failure to function.This was then replaced by a hawk s device, which was advanced through the recommended 6f sheath, but had resistance in advancing and retrieval.The crown got dislodged in the sheath, within the patient.The sheath was removed in toto and the crown was retrieved.Another similar incident also resulting in dislodging of crown within a separate patient happen the same week on monday.This is a similar concern that had resulted in class 1 recall by the fda.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC HAWKONE M AND S DEVICES
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 14021464
• MDR Text Key: 288809730
• Report Number: MW5108781
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H1-M
• Device Lot Number: 109156903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO ADVANTAGE WIRE; TERUMO SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Hispanic
• Patient Race: White