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 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a hawkone directional atherectory along with non medtronic 6fr sheath and 0.014 guide wire to treat a severely calcified lesion in the right mid sfa with 95% stenosis.The vessel was little tortuous.The vessel diameter and lesion length were 6mm and 25mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed during preparation, procedure and post procedure.It was reported that on second insertion of device, withdrawal through sheath became very tight.Physician applied moderate back pressure to pull nosecone into sheath and felt device give or a release of resistance.The tip was detached allowing remainder of nosecone to enter into sheath.The sheath/device was removed entirely and pressure was held to close arteriotomy.There was no patient injury reported.

Manufacturer Narrative

Additional information: there was no deformity in the nosecone reported until it got wedged inside of the sheath.It was at that point the separation of the nosecone occurred.  the entire nosecone was stuck inside of the sheath and no device parts were left in the patient.There was no deformation noted to the cutter.The cutter was contained inside of the housing during withdrawal of the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: a hawkone device was returned to the medtronic investigation lab (plymouth) for analysis.The device was returned within a sealed biohazard bag.No images were returned with the hawkone device.The device was removed from the return packaging for examination.The cutter driver was returned attached to the hawkone.A bend was noted in the torque shaft beneath the strain relief.A sheath and guidewire were also returned with the hawkone device.Inspection of the returned sheath revealed that it was a 6.0fr non-medtronic device, consistent with the reported event.A dried blood-like substance was noted inside the sheath tubing and around the sheath hub.The returned guidewire was protruding from the distal and proximal ends of the sheath.The guidewire was unable to be removed from the sheath.Multiple bends and kinks were noted along the length of the sheath.The kinks and bends were located approximately 10.3cm, 12.3cm, 13.1cm, 13.9cm, and 49.1cm proximal to the sheath distal tip.Microscopic examination of the sheath distal tip revealed a tear and stretching.The tear was pulled in the proximal direction.Examination of the returned guidewire revealed the distal tip was curved in a ¿j¿ shape.The outer diameter of the guidewire was verified by using a snap gauge from the lab; the guidewire outer diameter measured 0.0135¿, consistent with the reported guidewire.Microscopic examination of the guidewire revealed that the guidewire coating was worn away near the distal tip, likely from encountered friction.Inspection of the hawkone device revealed 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.Microscopic inspection of the cutter window revealed that the laser drilled coils had separated from the platinum iridium of the cutter window assembly cutter window.It was noted that the cutter window was bent.A blood-like substance was noted around the cutter window and drive shaft.Suspected pet was observed wrapped around the proximal end of the cutter head.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

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: 9334336
• MDR Text Key: 170791601
• Report Number: 9612164-2019-04778
• 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
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009810298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 02/05/2020; 01/19/2022
• Supplement Dates FDA Received: 11/27/2019; 02/05/2020; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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 Age: 74 YR
• Patient Sex: Male