MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number TH-LX-M

Device Problems Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use the turbohawk to treat a soft tissue lesion with 90% stenosis in the left mid, distal superficial femoral artery as per ifu.It was reported during the third re-entry into the patient the physician encountered difficulty closing the device.The turbohawk was removed and flushed as per ifu.Mixed in with the removed plaque was a small piece of clear plastic.The device functioned properly at that point but was not reintroduced into the patient.The procedure was completed using dcb with no issues noted.No patient injury reported.

Manufacturer Narrative

Photo analysis: the photo provided by the customer has been analyzed.The unknown material was inspected and showed characteristics similar to pet from within the housing of the distal assembly of the turbohawk.Device evaluation: the turbohawk was returned with a detached cutter driver and a folded piece of blue cloth.No other ancillary devices were included.The turbohawk was removed from the bag and inspected.It was observed the cutter was approximately 0.5 cm advanced distal the cutter window.No external damages to the turbohawk was noted.The blue piece of cloth was unfolded and found a rectangular piece of clear material.The material was and showed similar characteristics to pet from within the id of the housing assembly.The length and height was approximately 0.3 cm.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATK TURBOHAWK SMOOTH
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8239896
• MDR Text Key: 132801157
• Report Number: 9612164-2019-00165
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968424
• UDI-Public: 00643169968424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170191
• 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,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0009306243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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
• Patient Age: 67 YR