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

Catalog Number H1-M

Device Problems Use of Device Problem (1670); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

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-m device with a non-medtronic 6fr sheath and a 0.014, 6 mm spider fx embolic protection device during treatment of a 100 mm 90% stenotic lesion in the patient¿s mid distal left superficial femoral artery (sfa) of diameter 6 mm.Slight tortuosity and moderate calcification were reported.Ifu was followed and the device was prepped without issue.The vessel was not pre-dilated.After a few passes, the physician was having trouble getting the plunger to close.The device was removed for cleaning.It was noted that the cutter was uncoiled inside the cleaning device.The procedure was completed using another hawkone h1-m device.No patient injury was reported.

Manufacturer Narrative

Corrected product analysis: the hawkone was returned connected to a cutter driver.No other ancillary devices were included.The hawkone was inspected observed the thumb switch was advanced and the distal assembly was loaded the distal flush tool.With the distal flush tool, the tip assembly was fractured and separated.The coiled housing fractured at the proximal edge of where the laser drilled coils initiate (distal the anchor pockets).It was discovered the proximal portion of the separation showed the drive shaft and cutter assembly exposed.The drive shaft was looped around itself.The black duck-billed was removed from the dft and inspected the proximal end of the fractured housing.The housing showed the coil pulled proximally, the tecothane disengaged from the cutter window housing.The overall length of the fractured distal assembly was approximately 6cm.The proximal edge of the tecothane was rounded.The distal flush tool was broken apart in order to inspect the fracture face at the area of the cutter window.Approximately 2cm of the drive shaft was exposed outside of the fracture face with the cutter assembly attached.The proximal segment showed a radial fracture at the location where the coiled segment of the distal housing initiates.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the hawkone 6f h1-m was returned connected to the cutter driver.No other ancillary devices were included.The hawkone 6f h1-m was inspected.The cutter was retracted back into the cutter window.The cutter window distal rim was penetrated and pushed distal.A flap of the platinum iridium was noted within the housing lumen.The outside of the cutter window showed lateral creases to the platinum iridium.The thumb switch was advanced; however, the cutter crashed into the distal rim of the cutter window.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: 8797565
• MDR Text Key: 151288744
• Report Number: 9612164-2019-02905
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: H1-M
• Device Lot Number: 0009585826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 58