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

Catalog Number TH-LS-M

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Event Description

The physician was attempting to use a turbohawk atherectomy device to treat a lesion in the proximal sfa.The device was prepped as per the ifu with no issues identified.The device was advanced into the proximal edge of a stent and engaged a strut.It was reported in attempting to reposition the catheter, the thumb switch was pressed forward causing the blade of the device to clamp down on the stent strut.Efforts to disconnect the stent and atherectomy device were not successful.The atherectomy device and the stent were pulled from the body as a single unit.No alleged product issue.Angiographically and pulses ascertained via doppler indicate no damage to the patient.No intervention required or patient injury 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: 7199015
• MDR Text Key: 97491293
• Report Number: 2183870-2018-00023
• Device Sequence Number: 1
• Product Code: MCW
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TH-LS-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• 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