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

Model Number H1-S

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information: tip detachment occurred in the sheath.Procedure will be rescheduled at a later date.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review the customer provided a photo of the detached tip.Blood was observed within the inner diameter of the housing and on the exterior.The photo shows the distal assembly fractured apart.The fracture occurred distal the anchor pockets and at the proximal location were the laser drilled coils initiate.The drive shaft was exposed outside of the cutter window with the cutter assembly connected.The distal segment of the fracture showed a possible dent a the proximal area of the fractured housing.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 used a hawkone device with a 6fr non-medtronic sheath and spider fx embolic protection device to treat an 80mm fibrous lesion in the mid right superficial femoral artery (sfa) and popliteal artery of diameter 4mm.Slight vessel tortuosity and calcification are reported.The lesion exhibited 85% stenosis.Access was gained through the subclavian artery.The spider fx device was delivered past the lesion.The hawkone device was prepped as per ifu.Pre-dilation was not performed.Minimal resistance was encountered during advancement of the device.Advancement issues were encountered, and the physician moved the angiography equipment.It was noted the hawkone had prolapsed on itself at the subclavian site due to the sheath being too short.The device did not make it around the subclavian arch and down into the lower aorta.The physician then attempted to remove the device and the it is reported the distal tip sheared off the catheter.The detachment did not occur in the patient since it was wired over the wire.The physician was successfully able to pull both separated pieces back through the sheath over the wire for safe removal of the device from the patient.The procedure was ended at this point.No patient injury reported.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9151131
• MDR Text Key: 166082241
• Report Number: 9612164-2019-04219
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0009360820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0451-2022
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female