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

Catalog Number THS-LX-C

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

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 was attempting to use a turbohawk device to treat a soft tissue lesion with a cto (chronic total occlusion-100%) in the mid left superficial femoral artery.The lesion length and artery diameter were 200mm and 7mm respectively.The ifu was followed and the device was prepped without issue.It was reported that the nose cone broke off where the catheter meets the nosecone.No patient injury was reported.

Manufacturer Narrative

A spider fx device was also used in the procedure evaluation summary: the turbohawk device was returned for evaluation.The turbohawk was connected to a cutter driver.A broken wire was included.No other ancillary devices were included.The turbohawk and wire were removed from the box and inspected.The turbohawk showed the cutter/drive shaft exposed and advanced from the housing approximately 2cm.The fracture to the housing was observed where the laser drilled coils begin at the proximal end (distal the vent holes).One coil was stretched out from the housing.The distal segment of the housing which fractured off was not returned.The returned wire had characteristics which match that of a spider fx capture wire.The total length of the wire was 304cm.At approximately 174cm from the distal tip, the snap location of between the gold colored portion of the wire and black portion were identified.A loop/bend to the capture wire was identified at approximately 43cm from the distal tip.The distal end of the identified capture wire was bent at an approximate 45-degree angle and the ptfe appeared worn/skived.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
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7969867
• MDR Text Key: 123971811
• Report Number: 9612164-2018-02773
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684074008
• UDI-Public: 00821684074008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111723
• 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: 11/28/2018

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: 08/13/2020
• Device Catalogue Number: THS-LX-C
• Device Lot Number: A507712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 127