MAUDE Adverse Event Report: COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-LS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a hawkone device for the treatment of a lesion in the left distal superficial femoral artery (sfa).It is reported the catheter was acting like it was full, motor kept turning on, unless forward pressure was maintained.The thumbswitch was held forward but the cutter did not stop.Unable to determine if there was any deformation noted in the cutter or pieces missing.A new catheter was opened and used to complete the procedure.No patient injury reported.

• Brand Name: HAWKONE 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7509968
• MDR Text Key: 108148069
• Report Number: 2183870-2018-00269
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2019
• Device Model Number: H1-LS
• Device Lot Number: A383904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR