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

Model Number H1-S

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

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

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 6fr non-medtronic sheath and 0.014 non-medtronic guidewire during treatment of a plaque lesion in the patient¿s proximal, mid, and distal posterior tibial artery.Lesion exhibited 80% stenosis.Vessel pre-dilation was performed.Ifu was followed.It is reported that moderate resistance was felt during withdrawal of the device from the patient.The physician pulled the device through the end of the sheath and out of the patient.On removal, it was observed the tip of the device had detached and was not present.The detachment occurred at the hinge pin.The tip was lodged in the end of the sheath.The entire sheath and wire were removed as a unit and it is reported as it came though the arteriotomy the tipped remained in the vessel at arteriotomy site.Pressure held for hemostasis and patient taken to or for removal of tip.No further injury reported.

Manufacturer Narrative

Additional information: all components have been removed from the patient.The patient is fine with no complications.The patient has not been given any additional procedures or medications.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

Product analysis: the hawkone was returned to medtronic investigation lab for evaluation.The device was returned connected to a cutter driver.No other ancillary devices were included.A visual inspection of the returned hawkone was performed.The torque shaft beneath the strain relief was curved in an approximate 90-degree angle.The bend to the torque shaft was not likely relevant to the reported event and likely occurred during post-procedure handling.The distal assembly was inspected and found the distal rotating tip detached from housing.Dried blood was observed within the cutter lumen of housing.The guidewire tubing exhibited zipper tearing throughout the entire segment.The distal rim of the coiled housing showed the tecothane remained intact and not damaged however, the stainless steel coils within the housing were stretched out distally past the flush mouth.The damage observed to the stainless steel coil indicates exposure to excessive tensile force.The detached rotating tip was not returned.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: 10703726
• MDR Text Key: 212079626
• Report Number: 9612164-2020-04007
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• 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: 11/20/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0010145667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention