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

Model Number H1-S

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915)

Patient Problem Hematoma (1884)

Event Date 03/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an atherectomy along with non-medtronic 6fr sheath and 0.014" guidewire during procedure to treat a moderately calcified plaque lesion in the mid to distal right popliteal artery and posterior tibial artery (pta) with 80% stenosis.The vessel was little tortuous.The vessel diameter and lesion length are 3mm and 10mm respectively.The vessel was not pre or post dilated.Ifu was followed.It was reported that wire wrap occurred, physician somewhat forcefully removed sheath and then hawkone device caused tip damage to get the device out.The guidewire prolapsed and caused tip damage.The device was advanced over bifurcation.The guidewire was hydrated at preparation.After 6 or 7 passes with hawkone, physician pulled device quickly back and believes this caused the wire wrap.During withdrawal moderate resistance was felt and the tip of the device around the white tip was kinked.The hawkone was successfully used, there was no pta as physician pulled everything - sheath first, then hawkone and wire.Tip of hawkone device damaged by physician using forceps to pull device and wire from patient.Physician states device was not malfunctioning.Physician tried to remove device too fast causing wrap then pulled everything out.Patient had large hematoma after physician pulled sheath and then hawk one device out of patient- femstop used to stop bleeding and patient sent to hospital to monitor.There was no further patient injury.

Manufacturer Narrative

Device evaluation visual inspection of the detached tip shows that the white nosecone did not return for analysis.The detachment site at the end of the catheter is noted just distal to the anchor pockets and the cutter is visible at the end of the drive shaft with some metal coils surrounding the cutter.The distal end of the detached tip shows no white nosecone connected to the metal housing and the guidewire lumen is intact.The proximal end of the detached tip shows the metal housing stretched with biologics around the metal coils and within the housing.Due to the condition of the returned device no functional testing could be carried out.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 ; EI
• MDR Report Key: 11639738
• MDR Text Key: 244617219
• Report Number: 9612164-2021-01376
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0010455605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention