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

Model Number	H1-M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis report: the returned hawkone device was inspected and observed the torque shaft was bent approximately 90 degrees beneath the proximal strain relief.The distal assembly was inspected and noted the cutter assembly was completely retracted within in the cutter window.Visual evidence suggests the cutter head was making contact with the distal rim of the cutter window.Contact with the rim of the cutter window would prevent the ability to advance the cutter within the cutter window resulting in a cutter crash.It was discovered the outer distal rim of the cutter window showed the platinum iridium was penetrated.The location of the damage to the rim showed the platinum iridium was sliced.A 0.014" gw from the lab was inserted the distal flush mouth and pushed the debris within the laser drilled tip proximally towards the cutter window.Biological debris was observed and within the debris a metallic piece was discovered, likely from the rim of the cutter window.The characteristics of the metallic debris were consistent with platinum iridium from the cutter window.The device was soaked in water for approximately 24 hours.The debris was able to be removed using a needle-nose tweezers and separated the metallic debris from the biological.The approximate length of the metallic debris was 2mm.
Event or Problem Description
Physician was performing an atherectomy procedure on a lesion in the right superficial femoral artery using a hawk one device.The vessel was not pre-dilated.The lesion exhibited severe calcification, no tortuosity and 90% stenosis.It was reported the physician was unable to advance the thumb switch forward fully after each pass.After removing and cleaning the device, it failed to pack tissue into the nose cone.A second hawkone device was used to complete the procedure successfully.There was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6338211
• Report Number: 2183870-2017-00076
• Device Sequence Number: 1610460
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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,Followup
• Report Date (Section B): 01/18/2017

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: 10/10/2017
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: A346295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR