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

Catalog Number	P4028
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a silverhawk btk followed by a nanocross pta balloon during treatment of a calcified lesion in the patient¿s mid posterior tibial artery.Slight tortuosity and moderate calcification were reported.Ifu was followed.The atherectomy device was prepped without issue.It is reported that during removal of the device, it became wrapped and the tip separated but remained on the wire.The silverhawk and was removed in tandem with the sheath.Due to removal of the sheath access was lost and the procedure was completed at this point.No allegation against the nanocross device.Device not used in patient.No injury to patient.
Additional Manufacturer Narrative
Additional information: 6 passes were made with the atherectomy device prior to tip separation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation the silverhawk was loaded over the 0.0135" guidewire through the 5f cook sheath.The distal assembly of the silverhawk was fractured apart distal the rim of the cook sheath.Approximately 83cm of the guidewire was exposed outside the distal tip of the silverhawk.Approximately 2.5cm of curved/bent guidewire was visible between the fracture face of the distal assembly of the silverhawk.The fracture was ductile in nature the guidewire tubing was peeled out ward from the distal segment of the fractured distal assembly.The distal rim of the cook sheath showed signs of buckling and creases to the outer rim.The distal assembly portion which was located at the distal rim of the sheath was pulled out.The toque shaft guidewire tubing exhibited zipper tearing throughout the entire length.It was noted the guidewire lumen of the proximal segment of the distal assembly disengaged from the tecothane.The nanocross elite was inspected and found no damages or anomalies.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): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8649013
• Report Number: 9612164-2019-02055
• Device Sequence Number: 2173098
• Product Code: MCW
• UDI-Device Identifier: 00643169968455
• UDI-Public: 00643169968455
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2022
• Device Catalogue Number: P4028
• Device Lot Number: 0009638308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 08/15/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 08/07/2019; 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1