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

Catalog Number H1-LS

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a hawkone to treat a moderately calcified lesion with 90% stenosis in the mid right superficial femoral artery.The device was prepped as per the ifu with no issues identified.It was reported that following the second pass with the device, it became difficult to close.The device was removed without issue.While cleaning the device per ifu, a clear plastic sleeve was identified at the distal tip of the nosecone.The entire piece was removed with the included tweezers.The device operated normally at that point, but was not reintroduced into the patient.There is no patient injury reported.

Manufacturer Narrative

Device evaluation: the hawkone was removed from the packaging and inspected.No damage to the external components of the hawkone were noted.The distal assembly showed the cutter advanced approximately 2.5cm from the cutter window.Photos of the distal housing assembly were taken under microscope.The white cloth was unrolled and found the "clear plastic sleeve".The length of the clear material was approximately 4cm.One side of the material showed a flat/straight edge.The other side showed the material folded inward with a hollow end.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received to clarify event: it was reported that the device worked properly during the first entry into the patient.During the second entry, it worked for a few passes before the physician noticed some resistance closing the device.The device did close, but not completely but the cutter was inside the nosecone when it was removed from the patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8273315
• MDR Text Key: 133946321
• Report Number: 9612164-2019-00295
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• 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,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: H1-LS
• Device Lot Number: 0009340612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2018
• 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: 67 YR