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

Model Number	P4044
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a silverhawk directional atherectomy device to treat a moderately calcified lesion in the mid anterior tibial artery.The right tibial peroneal trunk had a distal 90% luminal diameter stenosis and the right anterior tibial artery had a 10mm hazy band in the proximal portion which the physician decided to perform a pressure pull back gradient which yielded a 44 mmhb pressure gradient.The artery was described as having moderate tortuosity with a 3mm diameter.The device was prepped as per the ifu with no issues identified.A non-medtronic 6fr 45cm sheath and a 0.014¿ no-medtronic guidewire was used during the procedure.The guidewire was hydrated during preparation.No resistance was felt during advancement and excessive force was not used.The physician stated the first pass felt fine but on the second pass the tip of the silverhawk on the guidewire felt as if it prolapsed.Very distal embolization occurred with no treatment required.The device was inspected and the customer stated it appeared the wire lumen of the device was torn.A kink was found on the device and the customer believe the damage occurred when the device was pushed forward.The procedure as completed with 3.0 mm x 200 mm balloon inflations.Patient is doing well.
Additional Manufacturer Narrative
Device evaluation summary: the silverhawk device was returned for evaluation.After the guidewire was unwrapped; the guidewire was inspected and noted a 90 degree bend approximately 17cm from the end with the gold colored segment.The outer diameter of the guidewire is 0.014" and the length is 300cm.The silverhawk was inspected and observed the guidewire tubing was torn from approximately 1.4 cm and the longitudinal tear continued to the proximal end of the tubing.It should be noted dried biologics was noted over the tear surface area.The torque shaft was bent at an approximate 45 degree angle beneath the strain relief.Functional testing: the returned guidewire was back-loaded which improved the visibility of the tears.The guidewire was pulled up on while loaded inside the guidewire tubing.No resistance was encountered and verified the zipper tearing was continuous.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: 6871254
• Report Number: 2183870-2017-00403
• Device Sequence Number: 10967466
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/17/2017

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: 04/12/2019
• Device Model Number: P4044
• Device Catalogue Number: P4044
• Device Lot Number: A443608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/17/2017
• 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: Other
• Patient Weight: 60