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

Catalog Number H1-M

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the hawkone was returned connected to a cutter driver.The hawkone was inspected.It was observed the torque shaft beneath the strain relief was bent at an approximate 45 degree angle.The distal assembly showed the laser coil segment was crushed approximately 2cm distal to the cutter window.Dried blood was observed within the lumen of the coil segment and cutter window.The torque shaft of the hawkone was run between two fingers and the surface felt rough throughout the shaft.The torque shaft was inspected under microscope and the hydrophilic coating of the hawkone showed uneven amounts or coating throughout the shaft.The coating appeared dull and porous where it appeared thicker and areas of the shaft were clear and smooth where to coating was either non-existent or thin.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a hawkone 6f with a 6f sheath and.014 guidewire, to treat a soft tissue lesion with 95% stenosis in the left mid superficial femoral artery as per ifu.It was reported that the hawkone crossed the lesion successfully, the hawk nosecone was packed and cleaned three times.The physician noted that on the third attempt the catheter shaft started to become very sticky.Resistance was felt when removing the device from the patient and on inspection, it was observed that the hydrophilic coating was coming off.The procedure was completed using angioplasty ballooning.No injury to the patient was reported.

• 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: 7506509
• MDR Text Key: 107992999
• Report Number: 9612164-2018-01051
• 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
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009015186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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