MAUDE Adverse Event Report: KANEKA CORPORATION THROMBUSTER II; THROMBUS ASPIRATION CATHETER

Catalog Number T2R8SA4W

Device Problem Break (1069)

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

Event Date 01/31/2014

Event Type  malfunction  

Event Description

This device (thrombuster ii) was employed for a thrombus aspiration in peroneal artery.When the device was tried to retrieve out of the vessel after the thrombus aspiration, the distal tip of the device was sheared off and remained on the guide-wire (gw) in the vessel.The physician inserted a new gw and rotated to entangle with the original gw, and successfully remove the distal out of the vessels together with the gws.

Manufacturer Narrative

The device concerned "thrombuster ii" has never distributed in u.S., however, is a similar device with "xpress-way rx extraction catheter" distributed in u.S.Under 510(k) number k101839.The structure of the aspiration lumen is different with each other.The actual product used was not returned for our further investigation.The device history record (dhr) of thrombuster ii with lot number kp093063 was reviewed and no nonconformity or abnormality was found in its manufacturing processes.The device met its material, assembling and product specifications.As a possible cause, we speculate as follows: the guide-wire (gw) formed a loop or a bend in the space between the proximal end of the guide-wire lumen of the device and the orifice of the gc, while retrieving the device through the gc, so that the device was stuck with the gc.Such the situation may happen when the device is retrieved into a gc too quickly and/or too strongly.While the distal tip of the device was unable to enter into the gc with a part of the gw bent outside the gc and the gw-lumene (inside the distal tip), the shaft of the distal tip sheared off with the gw by forcibly retrieving the device out of the vessel.

• Brand Name: THROMBUSTER II
• Type of Device: THROMBUS ASPIRATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; osaka ; JA
• Manufacturer (Section G): KANEKA CORP.; 2-3-18 nakanoshima; kita-ku, osaka 530- 8288; JA 530-8288
• Manufacturer Contact: masaharu inoue ; 546 fifth ave.; 21st floor; new york, NY 10036 ; 8005263522
• MDR Report Key: 3772681
• MDR Text Key: 21175248
• Report Number: 9614654-2014-00005
• Device Sequence Number: 1
• Product Code: MMY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/17/2014

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: 08/31/2016
• Device Catalogue Number: T2R8SA4W
• Device Lot Number: KP093063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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