MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7FR CATHETER, PERIPHERAL, ATHERECTOMY

Model Number T

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation visual inspection: the hawkone was inspected and found the distal assembly was stretched out at the proximal portion of the coiled housing edge and distal the anchor pockets. The tip remained attached connected to the housing. The tecothane was disengaged from the cutter window portion of the distal assembly. The proximal end of the guidewire tubing showed partial longitudinal tearing. The housing was bent approximately 3cm distal the cutter window. If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a hawkone atherectomy device with a spider fx during treatment of a calcified lesion in the patient¿s proximal right superficial femoral artery (sfa). Moderate vessel calcification is reported. Lesion exhibited 70-80% stenosis. Ifu was followed. Vessel pre-dilation was performed. Several passes were made with the hawkone device. When the physician attempted to insert the device to make the final pass, the physician felt severe resistance during advancement and the hawkone catheter could not be pushed forward due to it becoming entangled in the spider fx device. The physician then removed the hawkone catheter and spider fx. The procedure was completed using a non-medtronic (mustang) balloon and inpact pacific drug-coated balloon. The physician attempted to flush the spider fx and hawkone devices following removal from the patient and observed some plastic debris from the nosecone. The physician suspects the plastic debris is from the nosecone after several uses of the hawkone, as some part of the material peeled off from the nosecone. There was no detached components. The cutter was located inside the housing during device removal from the patient. No patient injury reported. When the device was returned to the manufacturing facility, it was noted that the device was damaged.

• Brand Name: HAWKONE 7FR
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11202321
• MDR Text Key: 227787319
• Report Number: 9612164-2021-00243
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: T
• Device Catalogue Number: H1-LS-INT
• Device Lot Number: 0010105781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial