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

Catalog Number H1-M-INT

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use the hawkone for treatment of the patients common femoral artery.It was reported that resistance was experienced while removing the device.The hawkone broke in the 6f introducer sheath near the end of the procedure and half of the nosecome was stuck in the introducer sheath which was in still in the patient.The device was removed safely and all components were removed from the patient during surgery.It was possible to turn off the thumbswitch.No patient injury was reported.

Manufacturer Narrative

Evaluation summary: the hawkone was returned for evaluation connected to a cutter driver.A portion of the spider fx was included with the distal assembly loaded over the capture wire with the filter assembly intact.No other ancillary devices were included.The hawkone was returned broken into two segments.The area of separation was a radial fracture where the laser drilled coils begin at the proximal end of the device.The proximal segment of the hawkone showed the cutter retracted back into the area of the fracture.The cutter was exposed with traces of biological debris around the cutter and the area of the fracture.One bent coil was observed to be stretched out distally at the location of the fracture.The distal segment showed the capture wire of the spider fx loaded over the rotating tip of the distal assembly.The filter of the spider fx was opened and located at the distal tip of the distal assembly which was 6cm long.The housing showed bending/flattening throughout the proximal end.The proximal end showed where the tecothane disengaged from the housing.Imprints from the vent holes were observed.The laser drilled coil(s) fractured within the tecothane coating.The guidewire tubing of the housing segment showed a zipper tear throughout the lumen.Traces of ptfe were observed between the housing and the rotating tip guidewire lumen - likely from the spider fx.The rotating tip showed the capture wire loaded; the proximal end of the wire tubing of the rotating tip was bent/pried upwards.Functional testing: the thumb switch was advanced and the cutter/drive shaft advanced approximately 2.8cm from the area of the fracture.No restriction was experienced upon advancing and the cutter advanced to complete a packing stroke.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 COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7994413
• MDR Text Key: 124660060
• Report Number: 2183870-2018-00476
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2020
• Device Catalogue Number: H1-M-INT
• Device Lot Number: A515370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75