MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ATK TURBOHAWK CALCIUM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	THS-LS-C
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 turbohawk atherectomy device during treatment of a calcified lesion in the patient¿s distal superficial femoral artery (sfa) of diameter 6 mm.Severe vessel calcification and moderate tortuosity are reported.Ifu was followed and the device was prepped without issue.It is reported the catheter jammed with the filter.This occurred when the procedure was almost finished.The physician removed the catheter from the patient safely and without injury.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: turbohawk device was returned to medtronic investigation lab for evaluation.The cutter driver was not returned.The ancillary device, the distal flushing tool was also returned.No images returned.A bend was noted in the distal housing located approximately 0.5-0.6cm distal to the cutter window.No further visual anomalies were noted with the turbohawk distal tip.The cutter was returned approximately 2.9cm distal to the cutter window.No biological debris was noted at the location of the cutter.Inspection of the cutter window revealed no anomalies.No damage was noted to the cutter window.The bend was also examined, it was noted that the inner laser drilled coils were bent slightly.The device was connected to a known good cutter driver from the lab.The cutter was able to successfully retract into the cutter driver.No anomalies were noted upon retraction.The device was able to advance approximately 2.9cm distal to the catheter window.No anomalies were noted during advancement.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
Additional information: it is unknown if vessel damage occurred.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
Additional information: there was withdrawal difficulties noted when the physician removed the device from the patient.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: ATK TURBOHAWK CALCIUM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9828128
• Report Number: 2029214-2020-00217
• Device Sequence Number: 16328748
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/14/2020

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: 08/04/2019
• Device Model Number: THS-LS-C
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A322033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/15/2020; 03/23/2020; 04/10/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/20/2020; 03/26/2020; 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1