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

Model Number H1-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a hawkone h1-s device with a non-medtronic 6fr sheath and a 0.014 extra support guidewire device during treatment of a 100mm plaque 75% stenotic soft tissue, moderately calcified and severely tortuous lesion in the patient¿s mid/proximal/distal peroneal artery of diameter 3-3.5mm.The device was inspected with no issues noted.The ifu was followed during preparation, procedure and post procedure and the device was prepped without issue.The vessel was not pre-dilated.It was reported that severe resistance was felt upon withdrawal through the sheath.The physician had to pull hard and the tip separated at the hinge and the nosecone came off.An antegrade stick and a snare were used to capture the nosecone.The patient was sent to step down for observation.No patient injury was reported.

Manufacturer Narrative

Additional information: the detached fragment was successfully removed.No deformation or missing parts were noted on the cutter post removal.Patient is doing well.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: two cine images were provided and one photo of fractured distal assembly.Both cine images show the distal assembly of the hawkone fractured off within the vessel.The fracture face of the proximal end of the distal assembly showed a coil stretched out proximally.The third image/photo provided showed the fractured off distal assembly outside of the patient.The fracture was identified distal the cutter window device evaluation the hawkone was removed from the packaging and inspected.It was observed the distal assembly was fractured apart.A radial fracture was observed between the anchor pockets and proximal end of the coiled segment of the housing.The distal end of the fractured off housing was not included with the returned contents.The proximal end of the separation showed a straight radial fracture.The cutter was located approximately 2.8cm distal the cutter window.It was discovered the cutter showed suspected pet wrapped around the od of the cutter head.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used a hawkone h1-s device e with a non-medtronic 6fr (ansel) sheath and a 0.014 extra support guidewire device during treatment of a 100mm plaque 75% stenotic soft tissue, moderately calcified and severely tortuous lesion in the patient¿s mid/proximal/distal peroneal artery of diameter 3-3.5mm.The device was inspected with no issues noted.The ifu was followed during preparation, procedure and post procedure and the device was prepped without issue.The vessel was not pre-dilated.It was reported that severe resistance was felt upon withdrawal through the sheath.The physician had to pull hard and the tip separated at the hinge and the nosecone came off.An antegrade stick and a snare were used to capture the nosecone.The detached fragment was successfully removed.No deformation or missing parts were noted on the cutter post removal.The patient was sent to step down for observation.No patient injury was reported.Patient is doing well.

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: 8508835
• MDR Text Key: 141751199
• Report Number: 9612164-2019-01308
• 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: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0009489776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG