MAUDE Adverse Event Report: COVIDIEN ATK TURBOHAWK CALCIUM; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number THS-LX-C

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a turbohawk atherectomy device in a procedure to treat a severely calcified plaque lesion in the mid sfa to popliteal with 70% stenosis.The device was prepped per ifu with no issues identified.It was reported that during the internal cutting process, the cutter fell into the collection chamber and fell off.The collection module was still connected to the device.The cutter head did not detach in the patient.The cutter fell in the collection chamber, not in the blood vessel.It was removed from patient.There was no patient injury reported.

Manufacturer Narrative

Additional information: the cutter was not exposed and it was removed from the patient.Another atherectomy device of a different model was used to complete the procedure.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.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.

Manufacturer Narrative

Corrected information: d3.Mfr name: product analysis: the turbohawk device was returned to medtronic for analysis.The device was received with an open sterile packaging.The turbohawk device was sealed within a non-sterile packaging.No ancillary device or images were returned with the device.The turbohawk was removed from the returned packaging for visual inspection.The turbohawk was returned attached to the cutter driver.The distal flushing tool (dft) was located over the distal housing.The cutter was advanced approximately 2.8cm distal to the cutter window.The device was activated, and the cutter was retracted into the cutter window.No anomalies were noted during retraction.No anomalies were noted with the cutter.The drive shaft remained attached to the cutter.The thumb-switch was then advanced.No issues were noted during advancement of the cutter into the housing.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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9236838
• MDR Text Key: 196415630
• Report Number: 2029214-2019-01079
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• Combination Product (y/n): N
• PMA/PMN Number: K111723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A527700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR