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

Model Number	P4030
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
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 was attempting to use a silverhawk atherectomy device during procedure to treat a lesion in the mid tibial arteries, at, pt, and peroneal.The lesion had moderate calcium.The device was prepped per ifu.It was reported that the cutter driver stopped working and the physician opened a new cutter driver.The device did not start with the new cutter driver.The physician removed the device to find the nosecone "shredded".The physician replaced the device with a turbohawk to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the cutter driver stopped working while inside the patient.There were no detached components inside the patient.The device was safely removed from the patient without intervention.The cutter was located inside the housing upon device withdrawal.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Additional Manufacturer Narrative
Device evaluation: visual inspection: the silverhawk was removed from the return packaging for examination.The cutter driver was not returned with the silverhawk catheter.Inspection of the catheter distal assembly revealed biological debris within the housing.It was noted that the proximal end of the orange guidewire lumen was partially inserted into the white shaft guidewire lumen.Two kinks were observed in the orange guidewire lumen.Inspection of the white shaft lumen found the lumen was torn and disengaged from the shaft approximately 4.8cm from the proximal end of the white guidewire lumen.There was no indication the guidewire tubing had fractured.Microscopic inspection of the orange guidewire lumen on the distal housing revealed no tears or anomalies.Inspection of the cutter window revealed the cutter was returned retracted into the window.Biological debris was noted distal to the cutter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: SILVERHAWK BTK
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9496977
• Report Number: 2183870-2019-00594
• Device Sequence Number: 2079309
• Product Code: MCW
• UDI-Device Identifier: 00643169968462
• UDI-Public: 00643169968462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/20/2020

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: 04/08/2022
• Device Model Number: P4030
• Device Catalogue Number: P4030
• Device Lot Number: 0009684741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 02/18/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 12/23/2019; 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1