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

Catalog Number P4034

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Occlusion (1984)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8124222
• MDR Text Key: 129032257
• Report Number: 2183870-2018-00555
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684074084
• UDI-Public: 00821684074084
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• 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 Outcome(s): Required Intervention