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Catalog Number H1-LS
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); Vascular Dissection (3160)
Event Date 09/12/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
Physician was attempting to use hawkone atherectomy device to treat a little calcified plaque lesion in the right proximal sfa with 85% stenosis. The vessel diameter and lesion length was 6mm and 80mm respectively. The device was inspected with no issues noted. The device was prepped per ifu with no issues identified. It was reported that the device broke, separated while trying to remove it from the body. The device had to be removed from the body, and outside of the sheath. A tear occurred at the access site. Protamine had to be given, and a long manual hold was performed.
Manufacturer Narrative
Additional information: it is unknown if the tip detached at the hinge pin. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Additional information: the tip of the device detached within the vessel but remained on the wire. The device was pulled out along with the sheath from the patient 's body. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Product analysis: the hawkone device was received for evaluation. A guidewire was also returned with the device. No images were received for review. The hawkone device was removed from the return packaging for visual inspection. A radial fracture was noted between the rotating distal tip. The outer diameter of the guidewire was verified by using a snap gauge from the lab; the guidewire outer diameter measured 0. 0135¿. The guidewire lumen of the distal housing was noted around the guidewire. A portion of the housing lumen remained attached to the guidewire. The returned guidewire remained loaded through the detached rotating distal tip. The guidewire extended approximately 47. 0cm distal to the distal end of the rotating tip. Multiple bends and kinks were noted throughout the guidewire. Bends were also noted at the distal end of the guidewire approximately 0. 9cm, 1. 3cm, and 2. 3cm proximal to the distal tip. It was noted that the coils were separated and stretched at the floppy end of the guidewire. Microscopic examination revealed two loops located along the guidewire, proximal to the hawkone rotating distal tip. At the location of the loop located nearest to the distal rotating tip, the 0. 2cm polymide tubing from the hawkone distal housing remained loaded onto the guidewire. Inspection of the guidewire lumen of the rotating distal tip, revealed that the proximal end of the lumen was torn and pulled distally. Further inspection of the guidewire revealed areas where the ptfe was scrapped away. The scraped ptfe suggests exposure to excessive frictional forces. Inspection of the hawkone distal housing revealed biological debris throughout the housing. Multiple bends were observed throughout the housing. Microscopic inspection of the joint connecting the distal housing to the rotating distal tip revealed no anomalies. The guidewire lumen showed disengagement of the guidewire lumen throughout the distal housing. Inspection of the laser drilled inner coils revealed the inner coils were bent inwards at several locations. Inspection of the proximal end of the distal housing revealed that the proximal end of the housing was torn, and the inner coils were exposed. The cutter was returned approximately 1. 4cm distal to the cutter window. If information is provided in the future, a supplemental report will be issued.
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Brand NameHAWKONE 7F
Manufacturer (Section D)
parkmore business park west
Manufacturer (Section G)
parkmore business park west
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key9070660
MDR Text Key158664753
Report Number9612164-2019-03940
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2022
Device Catalogue NumberH1-LS
Device Lot Number0009603204
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/16/2019 Patient Sequence Number: 1