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

Catalog Number P4030

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the silverhawk device was inspected and found the orange distal guidewire tubing disengaged from the proximal torque shaft guidewire tubing.The distal guidewire tubing was not torn; however buckling was noted approximately 0.3 mm from the proximal end of the distal guidewire tubing.The proximal guidewire tubing was inspected and discovered zipper tearing throughout the entire segment.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use the silverhawk directional atheterctomy device as per ifu, to treat a cto in the superficial femoral artery.A non-medtronic.014 300 guidewire and a 6 fr non-medtronic sheath were used.Artery diameter 6mm lesion length 100mm.It was reported the device was advanced to the lesion, made 2 passes with no issues noted.During removal of the device the physician encountered resistance, fluoro image showed a prolapsed wire in proximal sfa at the distal section of the device.The physician advanced the wire to straighten.The wire and device were removed intact as a unit.The wire was removed from the proximal port, a deformity was observed.No patient injury was reported.

• Brand Name: SILVERHAWK BTK
• 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: 7137134
• MDR Text Key: 95866728
• Report Number: 2183870-2017-00606
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684074046
• UDI-Public: 00821684074046
• 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
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: P4030
• Device Lot Number: A391677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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: 83 YR
• Patient Weight: 69