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

Model Number H1-S

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a hawkone-s directional atherectomy and everflex entrust self-expanding stent along with non-medtronic 6fr sheath and 0.014" guide wire during procedure to treat a severely calcified lesion in the right proximal anterior tibial artery (ata).The vessel is little tortuous.The vessel was not pre or post dilated.During initial advancement severe resistance was encountered and broken flush port occurred.The device was unable to cross the lesion.During procedure, the nosecone was broken and was retrieved by open surgery.It was reported that hawk was stuck at the level of the sheath upon removing it after it was not able to cross lesion in tibial artery.Physician tried to remove hawk and sheath at same time and nose cone broke off.It was snared but could not be removed out of body and patient had to go to surgery for endarterectomy and foreign object removal.Physician also tried to use the everflex entrust, the stent started deploying and then the wire inside the thumb wheel broke according to the physician and wheel was spinning but not deploying stent.The stent device was prepped per ifu with no issues identified.There was no damage to stent device packaging and no issues noted when removing device from hoop/tray.Deployment issue occurred with partial deployment reported.The thumbscrew/lock-pin was checked for securement prior to procedure.The lock-pin was removed after the stent was in place.Resistance was encountered while advancing the device.No force used.The device did not pass through a previously deployed stent.Physician used another stent to complete procedure.There was no further patient injury reported.

Manufacturer Narrative

Image review: the customer provided a photo of the distal portion of the distal assembly which was not returned.The distal portion of the housing was located inside a specimen cup.The housing was curved and showed evidence of blood on the exterior of the unit.The proximal fracture face was observed as the proximal edge where the coiled segment of the housing initiates.Product analysis: the hawkone was returned connected to a cutter driver with an unknown non-medtronic snare device.The non-medtronic snare device had a purple hub assembly.The distal end of the snare device did not show a hoop.It is possible the end of the snare may have fractured off.No other ancillary devices were included.The hawkone was inspected and found the distal assembly was fractured apart.A radial fracture of the housing was noted at the proximal edge of where the laser drilled coils initiate, distal to the anchor pockets.The distal portion of the housing was not returned.It was noted the cutter assembly was located within the cutter window.The cutter was advanced outside of the housing.It was identified pet was noted wrapped around the distal portion of the cutter head.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.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

Additional information: the partially deployed stent was safely removed from the patient though the sheath and no vessel damage was noted.The patient is doing fine, with no complications.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

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10559095
• MDR Text Key: 207699345
• Report Number: 9612164-2020-03521
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0010220509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0451-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male