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

Catalog Number THS-LX-C

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

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 device to treat a lesion in the sfa.The device was inspected and prepped per ifu with no issues identified.It was reported that it was impossible to advance the cutter into the housing after one single lesion crossing attempt.The device was used approximately 4 months post expiry date.No patient injury was reported.

Manufacturer Narrative

Additional information: no resistance was encountered advancing the device to the lesion.The device was safely removed from the patient, no deformation to the cutter was observed on removal.There were no issues packing the nose cone during the first passage.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the turbohawk was returned.No ancillary devices were included.The turbohawk was removed from the box and inspected.The cutter was advanced approximately 0.4 cm from the distal rim of the cutter window.Biological debris was observed within the housing assembly and on the outside the distal assembly.Bending of the housing was identified approximately 0.5cm from the distal rim of the cutter window.A cutter driver from the lab was connected to the turbohawk device.The thumb swich was retracted and the cutter was pulled back into the cutter window as intended.No damage to the cutter assembly was observed.Biologic debris was observed within the rim of the cutter.The thumb switch was advanced; however, resistance was encountered.The cutter advanced 5 cm.A distal flush tool from the lab was connected to the distal assembly.Water was flushed through the distal assembly and exited out the flush mouth.The thumb switch was advanced a second time, but the cutter would not advance past 0.5 cm from the cutter window.Damage to the laser drilled coils were noted at the area of encountered resistance.It should be noted the observed bend/dent was easier to identify after biologics were attempted to be cleaned from the housing.The reported event has been confirmed.It is likely tip damage encountered while inserted the vessel caused the cutter to meet resistance.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: 8353349
• MDR Text Key: 136605372
• Report Number: 2183870-2019-00077
• Device Sequence Number: 1
• Product Code: MCW
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A166181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1