MAUDE Adverse Event Report: COVIDIEN (IRVINE) SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	P4034
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a silverhawk device to treat a cto (chronic total occlusion) in a severely calcified and tortuous distal common iliac artery.The device was inspected prior to use with no issues noted.Ifu was followed and no issues were identified.It was reported that the nosecone broke off from the tip of the device in the superficial femoral artery leading to vessel occlusion.Patient was sent to surgery to remove the silverhawk nosecone.
Additional Manufacturer Narrative
Resistance was encountered when advancing the device through calcified plaque.Detachment occurred during removal of the device from the patient.The cutter window was closed when attempting to remove the device.Physician attempted to pin the nosecone up against the arterial wall using a stent unsuccessfully.Stent was also removed during surgery.Patient recovering from surgery.Device evaluation: the silverhawk was inspected and it was observed the flush port was cracked and pointed in a proximal direction.The distal end of the silverhawk was inspected and observed the distal end was separated.The separation occurred distal the cutter window.The cutter housing remained intact.The clear distal tip separated from the housing.The distal tip was not returned.The gw tubing of the torque shaft showed a zipper tear throughout the segment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8124222
• Report Number: 2183870-2018-00555
• Device Sequence Number: 1693548
• Product Code: MCW
• UDI-Device Identifier: 00821684074084
• UDI-Public: 00821684074084
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2019
• Device Catalogue Number: P4034
• Device Lot Number: A226960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention