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

Model Number H1-LX

Device Problems Contamination of Device Ingredient or Reagent (2901); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation the specimen container was opened and found a clear piece of suspected pet.The length was approximately 1cm.The suspected pet material at the rounded edge shows pet material pushed within the outer diameter.The hawkone was inspected and found the cutter advanced approximately 3cm distal the cutter window.No external damages to the hawkone were identified.Traces of dried blood was observed within the housing.The cutter was retracted and found no damages to the cutter assembly.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Physician was using a hawkone directional atherectomy during procedure to treat a little calcified soft tissue lesion in the right mid sfa with 99% stenosis.The vessel is a little tortuous.It was reported that after completion of multiple atherectomy insertions and cleaning, on the last cleaning, physician noticed some plastic in the nose cone that was flushed out.There was no issue with patient and procedure was completed without any issues.The foreign material as been included in the device returning.There was no patient injury reported.

Manufacturer Narrative

Additional information: the cutter was inside the housing and the device was safely removed from the patient.No deformation was noted to the cutter.No debris (clear plastic) detached in 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: 9450477
• MDR Text Key: 180241093
• Report Number: 9612164-2019-05102
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0009795153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• 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: 77 YR
• Patient Weight: 69