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

Model Number H1-M

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the hawkone was removed from the packaging and was inspected.A substance consistence with dried blood was observed in the distal ho using.The distal housing was detached at the hinge pin.The drive shaft remained intact.The distal housing remained attached to the catheter via the cutter which remained inside the cutter window and was unable to be removed.It was noted that the housing assembly was bent from the proximal to the distal end.Inspection of the hinge pins revealed that one of the hinge pins was damaged and deformed.The pin was pointing proximally.The proximal collar of the housing exhibited a flaring indicating that the tip assembly had been bent beyond the tilt limits of the hinge assembly.No damage was noted to the additional hinge pin weld.Inspection of the distal housing guidewire lumen revealed no anomalies.Inspection of the rotating distal tip guidewire lumen revealed tearing at the proximal end; no other anomalies were noted.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

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

Event Description

Physician attempted to use a hawkone directional atherectomy along with non medtonic 6fr 45cm sheath and.014 guide wire during procedure to treat a severely calcified lesion in the mid popliteal.The vessel diameter and lesion length are 3-5mm and 150mm respectively.The lesion was not pre dilated but post dilated.Ifu was followed.The device tip detached/damaged during advancement with severe resistance felt, with the tip separated at the hinge pin.It was reported that physician advance device in the sheath and right from the start, felt a lot of resistance and device was being advance through the aortic bifurcation while using fluoroscopy to image and follow how device was tracking.Physician pulled the device back and noticed that the nosecone had separated from the cutter.The device was in the sheath the whole time and since physician felt resistance, never pushed device into the patient¿s body.The whole catheter was safely removed from the sheath.Angiographic inspection was carried out to determine whether any piece was left in the sheath and confirmed that there was none.A new device was opened to continue the procedure.There was no patient injury reported.

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: 9719810
• MDR Text Key: 188637552
• Report Number: 9612164-2020-00765
• 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

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009947455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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