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

Catalog Number	P4044
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	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a silverhawk directional atherectomy catheter device during treatment of a slightly calcified lesion in the proximal posterior tibial artery.Lesion stenosis unknown.Vessel reported as being slightly tortuous.Device was prepped as per ifu without issue.Balloon angioplasty was performed.It is reported that the nosecone became lodged on the on the wire in the patient and after pulling on the device the nosecone detached and remained on the wire.A snare was used to retrieve the device.No further treatment was required.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the silverhawk was returned for evaluation.No ancillary devices were included.The silverhawk was returned with the distal assembly fractured and separated at the edge of the vent holes.The fracture observed was radial.The distal portion of the distal assembly which separated from the rest of the unit showed bending and uneven spacing between the coiled vent holes.The guidewire tubing showed signs of buckling at the proximal end.The damage observed was consistent with the distal assembly being subjected to excessive tensile forces.The cutter was advanced approximately 0.8cm from the cutter window.The cutter remained connected to the drive shaft.The platinum iridium showed a radial fracture.The guidewire tubing visible on this segment showed a longitudinal tear.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: 7453440
• Report Number: 2183870-2018-00239
• Device Sequence Number: 11172026
• Product Code: MCW
• UDI-Device Identifier: 00821684074107
• UDI-Public: 00821684074107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/20/2018

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: 09/21/2019
• Device Catalogue Number: P4044
• Device Lot Number: A527704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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: Required Intervention