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

Catalog Number	P4055
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
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
It was reported that the physician intended use a silverhawk to treat a 40mm severely calcified chronic total occlusion (cto) in the mid left common femoral artery.Moderate tortuosity was reported in the 7mm diameter artery.A 7fr non medtronic sheath and a 5mm spiderfx was used in the procedure.The vessel was pre-dilated.The ifu was followed.It was reported that the physician was unable to flush tissue from the device during cleaning.A second device was opened to complete the procedure.It was reported that moderate resistance was felt during withdrawal of the device and that the nose cone tip detached from the device at the hinge pin.The detached tip was removed from the patient and successfully cleaned.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the nosecone which had separated from the catheter remained attached to the system via the plunger/blade which connected the device shaft to the nosecone and all came out together over the wire.Nothing was left in the body.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: a silverhawk device was returned.The cutter driver was returned attached to the device.No ancillary device or images were returned for review.The silverhawk was removed from the packaging and was inspected.Biological debris was noted within the distal assembly.Black plunger was observed to be distal to the biological material.Distal assembly remained attached to the torque shaft adapter; the connection was loose.Microscopic inspection revealed the cutter window was full of calcified material.Inspection of the hinge pins revealed that one of the hinge pins was damaged and deformed.The pin was pointing proximally.The proximal collar of the housing exhibited a flaring; a tear was noted perpendicular to the hinge.The damage observed was consistent with the tip being bent beyond the tilt limits of the hinge assembly and the pin being forced tensionally.No damage was noted to the additional hinge pin weld.Inspection of the nosecone and the guidewire lumen revealed no anomalies.A 0.014¿ guidewire from laboratory stock was loaded onto the silverhawk device.No anomalies were noted with the guidewire lumen.The device was advanced into 7.0fr sheath and some resistance was noted; however, the device was able to be fully inserted into the sheath.The resistance was due to the observed hinge pin damage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK ATK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8498888
• Report Number: 9612164-2019-01258
• Device Sequence Number: 2758880
• Product Code: MCW
• UDI-Device Identifier: 00643169968431
• UDI-Public: 00643169968431
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/10/2019

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: 01/16/2021
• Device Catalogue Number: P4055
• Device Lot Number: 0009543498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 07/08/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/08/2019; 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1