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.

Manufacturer Narrative

Device evaluation 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.Photo analysis: the customer provided a photo of a clear piece which was likely discovered from the housing.The photo likely shows pet material from the inner lining from the housing assembly.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• 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
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 01/22/2023
• 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
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1