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

Catalog Number P4055

Device Problems Difficult to Flush (1251); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a silverhawk device with a 7fr sheath and 0.014 wire during treatment of a fibrous lesion in the patient¿s distal left superficial femoral artery (sfa).No tortuosity or calcification reported.Ifu was followed.Device prepped without issue.Pre-dilation was performed.It is reported that during the procedure, difficulty was experienced when trying to flush tissue.The thumb switch on the cutter driver would fully transition into the on and off positions.The cutter driver was released from the catheter and reattached.A new cutter driver was then connected.Due to the inability to fully open and close the cutter window due to the thumb switch, plaque was not able to be flushed from the nosecone.No damage noted to device.A second atherectomy device as opened to complete the procedure.No injury reported.

Manufacturer Narrative

Additional information: the thumbswitch on the cutter driver could not be completely turned off, it would not fully transition into the on and off positions.The device was safely removed from the patient.The cutter was inside the housing for removal, but the cutter window could not completely close.No deformation noted in the cutter if information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• 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: 8887204
• MDR Text Key: 154107719
• Report Number: 9612164-2019-03363
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968431
• UDI-Public: 00643169968431
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Catalogue Number: P4055
• Device Lot Number: 0009543498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• Date Device Manufactured: 01/17/2019
• 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