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); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

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 spider fx embolic protection device and 6fr non-medtronic sheath during treatment of a 60mm calcified lesion in the patient¿s proximal left superficial femoral artery (sfa).Slight vessel tortuosity and severe calcification are reported.Artery diameter reported as 6mm.Lesion exhibited 90% stenosis.Vessel pre-dilation was performed.Ifu was followed.It is reported severe resistance was noted during withdrawal of the hawkone device leading to a tip detachment.The tip separated at the hinge pin.It is suspected the spider fx kinked causing the hawkone to become stuck during the removal attempted.On removal of the device, the spider filter was reported to have been full and wouldn¿t go through the sheath.The physician pulled the entire sheath with devices out in tandem.The case was ended at this point due to loss access.No patient injury reported.

Manufacturer Narrative

Additional information: no damage was noted to the device packaging.None of the components of the spider fx detached.The nosecone broke off in the sheath and all components were removed within sheath.All components of the devices were removed from the patient.No additional treatment has been given and the patient is doing fine.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.

Manufacturer Narrative

Device evaluation visual inspection: a visual inspection of the all the returned devices was conducted.An inspection of the distal rim of the sheath showed not damage, but dried blood was noted.The spider fx capture wire was loaded through the sheath.The distal end of the spider fx capture wire showed the distal housing assembly fractured off.The distal end of the filter wire showed the coiled tip of the filter assembly was not present.The coiled tip fractured off approximately 0.5cm distal the distal marker band of the filter.Biologics were observed captured within the filter.The distal assembly loaded over the capture wire showed the platinum iridium coil stretched out proximally past the tecothane.No zipper tearing was noted.The capture wire was bent at an approximate 45degree angle at the area of the gw tubing of the distal assembly housing.Proximal to the detached housing the capture wire was looped and curved.At the areas of bending, the ptfe was scraped off, which indicates likely encountered friction.The proximal segment of the returned hawkone showed the distal flush tool placed over the fracture location of the distal assembly.The black duck-billed valve was removed and blue fibers were observed.The hawkone distal end could not be removed from the dft.An inspection though the dft showed the cutter assembly remained intact and attached to the drive shaft.The fracture face of the housing was radial and occurred at the proximal edge of where the coils begin on the housing and distal to the anchor pockets of the housing.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: 10703693
• MDR Text Key: 219345285
• Report Number: 9612164-2020-04004
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010192930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR