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); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a hawkone device with a 6fr non-medtronic sheath and spider fx embolic protection device during treatment of a 100 mm calcified lesion in the patients common iliac and superficial femoral artery.Vessel diameter reported as 7 mm.Slight vessel tortuosity and severe calcification are reported.Lesion exhibited 70% stenosis.Ifu was followed.Atherectomy completed successfully.Moderate resistance was encountered during withdrawal.It is reported that wire wrap in the calcified artery occurred resulting in tip detachment.The tip separated at the hinge pins.The nosecone is reported to have broken off below the blade.A snare was used to retrieve the detached portion.No injury reported.

Manufacturer Narrative

Image review: one cine image and one photographic image were returned for review.The cine image appeared to contain the distal assembly of the hawkone device during patient use.Due to the quality and clarity of the returned cine image, the specific location of the possible separation of the distal assembly could not be determined.The returned photograph contained the detached distal tip of the hawkone device; the remainder of the catheter, including the cutter, cutter window, torque shaft and cutter driver were not included within the photograph.The device exhibited a radial fractured distal to the cutter housing anchor pockets.A guidewire remained loaded through the distal assembly guidewire lumen.Blood and biological debris were noted in the housing of the distal assembly.The returned images were consistent with the reported tip detachment.Product analysis: a hawkone device was returned to the medtronic investigation lab (plymouth) for analysis.The device was returned within multiple closed plastic bags.A device label sticker was adhered to the outside of one of the plastic bags.The sticker indicated lot number 0009843169, consistent with the reported device.No ancillary device was returned with the hawkone and cutter driver.The device was removed from the return packaging for review.The device was returned connected to the cutter driver.A bend was noted in the torque shaft beneath the strain relief.The hawkone was inspected and found the distal assembly was fractured apart into two pieces.The fracture occurred at the proximal end of the housing where the coils initiate, distal the anchor pockets.The cutter assembly attached to the drive shaft was protruding out approximately 2.2cm.The radial fracture was located distal the anchor pockets and at the proximal edge of the coiled segment of the housing.A portion of the inner laser drilled coils remained wrapped around the drive shaft.Microscopic inspection of the cutter window revealed that the laser drilled coils had separated from the platinum iridium of the c utter window assembly cutter window.The laser drilled coils were bent and stretched distal to the to the cutter window.Suspect pet and biological debris was noted throughout the laser drilled coils.The distal portion of the laser drilled coils revealed stretching and the distal ends of the coils were fractured.The fracture faces were rounded in nature.Examination of the cutter revealed no anomalies.The distal segment of the distal fracture was not returned, which included the main segment of the housing assembly and rotating tip.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: a spider wire wrapped occurred in the calcified artery.All device components, including the hinge pins, were removed from the patient.Following removal of the detached portion, was the procedure completed.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.

• 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: 9334267
• MDR Text Key: 166738796
• Report Number: 9612164-2019-04775
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• 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,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009843169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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-0450-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male