MAUDE Adverse Event Report: KANEKA CORPORATION THROMBUSTER II; CATHETER, EMBOLECTOMY

Catalog Number T2R8SA4W

Device Problems Break (1069); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) of the device concerned were reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test (including the welded part of the distal tip) and the internal diameter measurement of gw lumen for every product, and the finished product inspections including the shaft tensile strength test and the withstand absorption pressure test on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The actual device concerned was returned and investigated: the distal tip (gw lumen shaft) was torn off from the catheter shaft (suction lumen shaft).Many small axial scratches were observed on the surface of the catheter shaft (especially, until the 30 mm from the distal).No particular damage or abnormal feature was observed on the other parts.Probable cause(s) and our comment: when the catheter was removed, the distal tip was trapped in the highly calcified cto lesions.(at this time, the small axial scratches on the catheter shaft were occured).Further attempt was made to pull out the device forcibly while the distal portion was trapped in the lesion.Then the distal tip trapped in the lesion was ripped away from the shaft.This situation may happen when operators try to pull the thrombuster ii into a gc (or a sheath device) too quickly and/or strongly.We believe the reported event was caused by not a defect or malfunction of the device but by a device handling issue.

Event Description

The device concerned "thrombuster ii" which has never distributed in us is similar to "xpress-way rx" distributed in us under 510(k) # k101839.The structure of the aspiration lumen is different from each other.The thrombuster ii was approached from above knee (ak) to highly calcified cto lesions of the anterior tibial artery (ata).After the thrombus aspiration, the physician had a feeling of strangeness while the catheter was removed and noticed that there was no distal part of the catheter.The broken distal tip was retrieved through the sheath by pushing it up using coyote balloon dilatation catheter (boston scientific, 2.0 mm).

• Brand Name: THROMBUSTER II
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 8255618
• MDR Text Key: 133316733
• Report Number: 3009761573-2018-00022
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: T2R8SA4W
• Device Lot Number: KP098143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention