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

Catalog Number	H1-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: the hawkone was returned inside a previously opened hawkone box which indicated lot a519421.Within the box, the hawkone was stored loosely connected to a cutter driver.The hawkone was inspected and the cutter assembly could be seen retracted back into the cutter window of the distal assembly.Dried blood was observed within the lumen of the distal assembly and outside.Under microscope it was observed the hypotube and drive shaft had fractured apart.No other damages to the hawkone device were noted.The thumb-switch was moved back and forth.The cutter assembly did not move from its original position in which it was received.
Event or Problem Description
The physician used a hawkone atherectomy device to treat plaque and soft tissue lesions with little calcification in the left proximal tibial artery and popliteal trunk.The lesions lengths were 15-20 mm and the artery diameters were 2-5 mm.The arteries had little tortuosity.The device was prepped as per the ifu with no issues identified.The procedure used a 6 fr 55 cm sheath and a non medtronic 300cm guidewire.The vessel was pre and post dilated.Pre dilation was carried out with a nanocross device and post dilation was carried out with a drug coated balloon(dcb).Following the second round of cutting the button of the device would not go forward and became stuck.The device was removed safely from the patient but it was unknown if the cutter had returned into the housing on removal.Angiogram showed good run off.No patient injury was reported.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 7175497
• Report Number: 2183870-2018-00009
• Device Sequence Number: 16610350
• Product Code: MCW
• UDI-Device Identifier: 00643169792319
• UDI-Public: 00643169792319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2020
• Device Catalogue Number: H1-S
• Device Lot Number: A519421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 85