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

Catalog Number P4056

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use the silverhawk directional atherectomy device to treat a soft tissue lesion, with little tortuosity, no calcification and 99% stenosis in the mid superficial femoral artery(sfa) as per ifu.The device was prepped per ifu with no issues identified.It was reported after two passes the device jammed and became excessively difficult to close.No injury to the patient was reported.

Manufacturer Narrative

The thumbswitch stopped functioning in the patient immediately following the second pass.The thumbswitch was successfully turned off but excessive force was required.The cutter was positioned inside the housing and the power was turned off.The device was safely removed from the patient.No deformation was noted in the cutter.A balloon and stent were used to complete the procedure.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): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8063633
• MDR Text Key: 127368682
• Report Number: 9612164-2018-03159
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684074169
• UDI-Public: 00821684074169
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2018
• Device Catalogue Number: P4056
• Device Lot Number: A370139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 12/11/2018
• Date Device Manufactured: 11/03/2016
• 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: 67 YR
• Patient Weight: 76