MAUDE Adverse Event Report: COVIDIEN (IRVINE) ATK TURBOHAWK SMOOTH; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number TH-LX-M

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the turbohawk was inspected and observed the distal assembly showed the laser drilled coils bent/compressed at approximately 1.5 and 6cm from the cutter window.The cutter assembly was visible within the cutter window.The torque shaft was bent at an approximate 45 degree angle beneath the strain relief.The cutter driver was powered on and the thumb-switch was retracted.The cutter assembly retracted back into the cutter window as intended.The thumb-switch was pushed forward, however resistance was encountered.The cutter head was able to advance approximately 0.3cm from the cutter window.It was observed the outer diameter of the laser drilled tip was bent inward.The edge of the cutter head was contacting the inner diameter of the distal assembly at the location of the observed bend.The cutter was unable to advance within the distal assembly due to a blocked cutter lumen from a bend inwards of the laser drilled tip.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.

Event Description

The physician was using a turbohawk directional atherectomy device to treat a moderately tortuous and moderately calcified mid left sfa lesion exhibiting 75% stenosis and plaque.The device was removed from the packaging and inspected with no issues noted.The device was prepped per the ifu.It was reported that the physician successfully inserted the device into the patient, made six passes, then removed and cleaned the device before re-advancing the device through the sheath and making several more passes through the lesion.The physician reported that they were unable to turn the device on and off without the thumbswitch sticking while at times, being used in the patient.It was reported that the device was sticking while the cutter was both inside and outside the housing.No patient injury was reported.

• Brand Name: ATK TURBOHAWK SMOOTH
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6863940
• MDR Text Key: 86148438
• Report Number: 2183870-2017-00391
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684065754
• UDI-Public: 00821684065754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: TH-LX-M
• Device Lot Number: A324231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1