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

Catalog Number THS-LS-C

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use a turbohawk atk device to treat a 60% stenotic, calcified plaque lesion in the left mid superficial femoral artery(sfa).No tortuousity was reported.The device was preped as per ifu and inspected with no issues identified.The physician carried out the first cut but the cutter head could not return to the housing.No patient injury was reported.

Manufacturer Narrative

Device evaluation the turbohawk was inspected and noted the cutter was advanced within the cutter housing of the distal assembly.No other damages or anomalies to the turbohawk were noted.Functional testing: the thumb switch was retracted.The cutter pulled back into the cutter window as intended.No damage to the cutter assembly was observed.The turbohawk was connected to a cutter driver and activated.The cutter was able to advance to approximately 1.5cm distal the cutter window.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: 8296197
• MDR Text Key: 134713662
• Report Number: 2183870-2019-00053
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684065785
• UDI-Public: 00821684065785
• 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
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: THS-LS-C
• Device Lot Number: A488656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR