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 Device Embedded In Tissue or Plaque (3165)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) of the device concerned was reviewed: the production lot, to which this particular device concerned belongs, passed all in-process inspections including the visual inspection and the internal diameter of the guidewire lumen for every product, and the finished product inspections including the shaft tensile strength and the aspiration lumen integrity against negative aspiration pressure on representative samples based on the predetermined sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.Probable cause(s) and our comment: while the thrombuster ii catheter was attempted to pull back into the guiding catheter (gc), the guidewire (gw) became separate apart from the catheter shaft of the thrombuster ii to make a loop or bend in a space between the gw port of the thrombuster ii and the orifice of the gc, and it made difficult to further pull back the thrombuster ii.Then, further attempts to forcibly retrieve the thrombuster ii resulted in splitting the catheter shaft of the thrombuster ii to by the gw with the distal tip (the gw lumen) of the thrombuster ii on it.Such 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 the user's device handling issue.Since the distal tip with a radiopaque marker (about 1 cm long) dismounted from the split catheter shaft, should have remained on the gw, the physician should have been able to remove the distal tip out of the patient's vessel together with the gw by a cautious operation.However, the physician accidentally withdraw the gw without noticing the dismounted distal tip on it, the short distal tip dropped off from the gw and flown away to the peripheral artery.

Event Description

The thrombuster ii was applied to highly calcified lesions of the superficial femoral artery (sfa).Since thrombus was proliferated in large amount in the sfa lesion, the thrombus aspiration was repetitively conducted in more than 4 hours, and the total procedure time took over 6 hours.In the late stage of the thrombus aspiration, the physician noticed that there was no radiopaque marker at the distal tip of the thtombuster ii catheter on fluoroscopy.When the catheter was checked outside the body, the distal tip including the guidewire lumen had been torn off.The distal tip remained in the peripheral artery of the lower limb of the patient.Since the distal tip completely reached the extremity of the foot and did not appear to move, it was judged that there was no problem in the remaining state.Additional treatments such as the removal of the distal tip were not carried out.The device concerned "thrombuster ii" has never distributed in us, however, is a similar device with "xpress-way rx extraction catheter" distributed in us under 510(k) # k101839.The structure of the aspiration lumen is different with each other.

• 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: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka-city,, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 7057313
• MDR Text Key: 92839222
• Report Number: 3009761573-2017-00006
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: T2R8SA4W
• Device Lot Number: KP087510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2017
• 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): Other
• Patient Age: 84 YR