MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number P4044

Device Problems Misfire (2532); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

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 silverhawk device with a 6fr sheath and non-medtronic guidewire during treatment of a plaque cto (chronic total occlusion-100%) in the patient¿s mid and distal popliteal artery and anterior tibial artery.No vessel tortuosity or calcification reported.Ifu was followed.Vessel pre-dilation was not performed.It is reported the device did not engage with the plaque.The device was safely removed from the patient.It is unknown about the position of the blade relative to the housing during removal of the device.There was no deformation noted in the cutter.The device was replaced with another atherectomy device to complete the procedure.There was no vessel damage noted.No patient injury reported.

Manufacturer Narrative

Product analysis: the silverhawk was returned inside a biohazard bag with a device label attached which indicated lot 0009882970.The silverhawk was inspected.The cutter was located within the cutter window.Dried blood was observed behind and in front of the cutter.The coiled housing showed a gradual bend at approximately 1cm distal the cutter window.No damages were noted to the silverhawk drive shaft or thumb switch assembly.The silverhawk was attached to a cutter driver from the lab.With the cutter driver activated the cutter could not advance within the housing.The distal assembly was soaked in water and the cutter was unable to advance.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK BTK
• 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: 9937927
• MDR Text Key: 188119131
• Report Number: 9612164-2020-01529
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968479
• UDI-Public: 00643169968479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• 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
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Model Number: P4044
• Device Catalogue Number: P4044
• Device Lot Number: 0009882970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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: 40 YR