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

Model Number H1-M

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone device during treatment.Ifu was followed.It is reported the physician was unable to advance the thumbswitch to pack the device after completing the initial pass.It was reported that the cutter was located outside the housing for removal of the device from the patient.The device was safely removed from the patient.The device was replaced to complete the procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the hawkone was returned along with the cutter driver to medtronic investigation lab for evaluation.No other ancillary devices were included.The hawkone was inspected and found the distal flush tool was located over the distal assembly.The distal flush tool was pulled off from the distal assembly.No external structural damage to the distal assembly as observed.The cutter was positioned approximately 0.3cm from the cutter window.Biological debris likely collected during treatment was noted distal to the cutter assembly.No damages or anomalies were observed to the hawkone.The cutter driver was activated and retracted the thumb switch.The cutter was able to pull back into the cutter window as intended.The cutter was advanced, however resistance was noted at approximately 0.4cm distal the cutter window where the biological debris was noted.The distal flush tool was placed over the distal assembly and flushed with water.The thumb switch was advanced and the cutter was able to advance within the housing completing a packing stroke.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9947632
• MDR Text Key: 187949796
• Report Number: 9612164-2020-01543
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009909227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1