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

Model Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Compatibility Problem (2960); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the tip has been removed from the patient and the patient is doing well.Correction: patient was sent to or to remove the detached tip.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 intended to use an hawkone with a 6fr non-medtronic sheath and 0.014 non-medtronic guidewire during treatment of a calcified lesion in the patient¿s proximal right superficial femoral artery (sfa).Moderate vessel calcification is reported.Ifu was followed.Vessel pre-dilation was performed.It is reported resistance was noted when withdrawing the device and the tip detached.The patient was sent for surgery to remove the detached tip.No further injury reported.

Manufacturer Narrative

Additional information: moderate to severe resistance was experienced when trying to pull the device back into the sheath during removal attempt.The tip was removed from the patient during a different surgery in an open manner during a cutdown procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation the hawkone was inspected and found the distal assembly fractured off at the coiled segment and was not returned.Approximately 21cm of the guidewire was exposed outside of the introducer sheath.The distal end of the exposed guidewire shoed the wire looped/curled.Consistent with damage observed after a prolapse event.The distal end of the introducer sheath showed buckling for approximately 2cm from the distal tip.The cutter assembly was exposed from the housing likely showing pet over the cutter blank of the cutter assembly.The pet did not extend over the cutter rim.The fracture of the distal assembly occurred distal to the anchor pocket and at the proximal edge of where the coiled segment initiates.The fracture was radial and the tecothane was not covering the anchor pockets.It is likely the tecothane remained bonded to the distal portion of the assembly that was not returned.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: 9768665
• MDR Text Key: 182473825
• Report Number: 9612164-2020-00930
• 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,Followup,Followup,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009698858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/03/2020; 03/03/2020; 03/05/2020; 04/13/2020
• Supplement Dates FDA Received: 03/05/2020; 03/05/2020; 03/09/2020; 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86