MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-03-17 for THROMBUSTER II T2R8SA4W manufactured by Kaneka Corporation.
[21175248]
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.
Patient Sequence No: 1, Text Type: D, B5
[21280611]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614654-2014-00005 |
| MDR Report Key | 3772681 |
| Report Source | 01,05 |
| Date Received | 2014-03-17 |
| Date of Report | 2014-03-17 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2014-02-17 |
| Date Added to Maude | 2014-05-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MASAHARU INOUE |
| Manufacturer Street | 546 FIFTH AVE. 21ST FLOOR |
| Manufacturer City | NEW YORK NY 10036 |
| Manufacturer Country | US |
| Manufacturer Postal | 10036 |
| Manufacturer Phone | 8005263522 |
| Manufacturer G1 | KANEKA CORP. |
| Manufacturer Street | 2-3-18 NAKANOSHIMA |
| Manufacturer City | KITA-KU, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THROMBUSTER II |
| Generic Name | THROMBUS ASPIRATION CATHETER |
| Product Code | MMY |
| Date Received | 2014-03-17 |
| Catalog Number | T2R8SA4W |
| Lot Number | KP093063 |
| Device Expiration Date | 2016-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-17 |