MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-10 for ASAHI CHIKAI BLACK WAIN-CKI-200-BS manufactured by Asahi Intecc Co., Ltd..
[96936325]
(b)(4). Attempt was made to gather thorough event information during complaint processing; the physician commented that the patient had been fine without problem after the procedure. The subject guide wire was returned for evaluation. The returned guide wire was not bent or deformed. At approximately 58-60cm from the proximal wire end, damaging of the polymer jacket was found. Damaged polymer jacket was microscopically observed. It revealed that at approximately 58cm from the proximal wire end, the polymer jacket was torn due to ductile stress. Distal to that point, the polymer jacket was found intermittently peeled off. Some damaged portion of the polymer jacket was torn helically and remained attached on the wire shaft; linear scratches were observed on the remaining polymer jacket. To replicate this malfunction, a torque device was attached on an unused guide wire of the same kind, lightly fastened so that the metal wire fixture of the torque device would contact the wire surface, and then rotated. After removal of the torque device, the wire polymer jacket was observed. Similar damage condition that was found on the subject guide wire, tearing of the polymer jacket due to ductile stress and helical peeling of the polymer jacket, was seen on the test guide wire. Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received. Based on the obtained information and results of device investigation and replicate testing, it was concluded that the polymer jacket of the subject guide wire was peeled off due to excess abrasion caused by a metal wire fixture of the torque device that scraped the surface of the subject guide wire. There was no indication of product deficiency. Damaging of the polymer jacket was too severe to rule out a possibility that fragment(s) of the polymer jacket might have entered in the vasculature, and thus this event was considered possible serious injury. Instructions for use states: [precautions] do not manipulate the guide wire with a torque device other than the supplied torque device. When attaching a torque device to the guide wire, or manipulating the guide wire using a torque device, carefully manipulate the guide wire, so that the guide wire will not be damaged. Fasten the torque device with care not to excessively fasten it; and, [malfunction and adverse effects] coming off of coating.
Patient Sequence No: 1, Text Type: N, H10
[96936326]
It was reported that during a transcatheter arterial chemo-embolization (tace) procedure, the subject guide wire was interested in the anatomy with a torque device attached. When the torsion was applied to the guide wire via the torque device, peeling of the polymer jacket of the guide wire was recognized. A new guide wire was replaced and the procedure was continued and completed without problem. Reportedly, there were no adverse patient effects and no additional interventions were taken against this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2018-00006 |
| MDR Report Key | 7181420 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2017-07-27 |
| Date Added to Maude | 2018-01-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YUKAKO HOMMA |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 489-0071 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 489-0071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI CHIKAI BLACK |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2018-01-10 |
| Returned To Mfg | 2018-01-05 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200-BS |
| Lot Number | 170720A30A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI INTECC CO., LTD. |
| Manufacturer Address | 3-100 AKATSUKI-CHO SETO, AICHI 489-0071 JA 489-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-10 |