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

Model Number H1-M

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

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 6fr non-medtronic sheath and 0.014 non-medtronic wire during treatment of a calcified lesion in the patient¿s mid and distal right superficial femoral artery (sfa).Slight vessel tortuosity and moderate calcification are reported.Lesion exhibited 85% stenosis.Ifu was followed.Vessel pre-dilation was not performed.It is reported that moderate resistance was noted during withdrawal of the device resulting in the tip detaching in the sheath.The tip on the device was removed with a snare and the procedure was completed with a pta balloon.No patient injury reported.

Manufacturer Narrative

Additional information: the cutter was located inside the housing during device removal from the patient.No vessel damage was noted.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation the hawkone was returned with the tip fractured apart.The location of the radial fracture was at the proximal edge of the laser drilled coils segment of the distal assembly, distal to the anchor pockets.The fracture face was inspected under microscope and found the tecothane was intact and folded over.The anchor pockets were visible and shows the tecothane disengaged from the cutter window housing.It was observed the proximal end of the guidewire tubing was torn and disengaged from the housing.A coiled segment (platinum iridium) was stretched out past the tecothane.A non-medtronic snare device was returned.No components of the hawkone were noted within the loop of the snare.The cook introducer sheath was inspected and found buckling at the distal end and at approximately 8cm from the distal tip.The other segment of the hawkone was inspected and found one coil stretched out distally approximately 0.3cm.The fracture was consistent wit exposure to excessive tensile forces.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 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10337474
• MDR Text Key: 200760995
• Report Number: 9612164-2020-02781
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010155365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 91