MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-30 for ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[74160584]
Manufacturing site: manufacturing site could not be determined because the product lot number information was not available. Attempts were made to gather thorough event information during complaint processing; the physician commented that although resistance was felt between the guidewire, he resumed the procedure. He had never felt such resistance during procedure. He thought felt resistance was caused by the catheter. There were no adverse impacts on the patient after the procedure. The returned guidewire had its coil wire elongated approximately 40 cm in length starting at approximately 25mm distal to the proximal solder located 30 cm from the tip. Under the elongated coil wire, the inner coil wire was exposed approximately 7cm in length. The elongated coil wire was observed under a microscope. It revealed that the distal end of the coil wire had a trace of soldering and had cut surface that was made during manufacturing process. These findings suggested the coil wire was not fractured. The inner coil wire also had a trace of soldering at its distal end; therefore, it was concluded that there was no fracture on the inner coil wire. Approximately 1 cm from the distal end of the inner coil wire, the core wire was exposed. The distal end of the core wire had cut surface that was made during manufacturing process; it was concluded that the core wire remained in one piece. Investigation of the production record could not be performed as lot information was unavailable. Although lot history review could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of product deficiency. Based on the obtained information and above investigation outcome, it was concluded that damages found on the guidewire was contributed by a concomitant catheter that was flattened during procedure due to the anatomy, that deformation increased resistance, and deteriorated the wire slidability. While the guidewire was under increased resistance, pulling force along with wire manipulation caused the core wire to be separated from soldering of the tip and led the coil wire to be elongated. There was no indication of product deficiency. Ifu states: - [warnings] never push, auger, withdraw, or torque a guidewire that meets the resistance. Torquing or pushing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation or direct damage to a vessel. Resistance may be felt and/or observed under fluoroscopy by noting any bucking of the guidewire tip. If guidewire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guidewire may occur. Determine the cause of resistance under fluoroscopy and take any necessary remedial action; - [warnings] if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire. Stop the procedure. Determine the cause of resistance under fluoroscopy and take appropriate remedial action. If the guidewire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; and, - [malfunction and adverse effects] breakage or bending of the guide wire, damage such as separation.
Patient Sequence No: 1, Text Type: N, H10
[74160585]
During a procedure to treat acute cerebral infarction in the right mca m1 and left mca1 and 2, a non-asahi microcatheter and an-asahi guidewire were advanced to the target infarction. The guidewire was able to cross the target; however, strong resistance was felt and microcatheter could not follow the guidewire. The device system was exchanged to new one and the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2017-00063 |
| MDR Report Key | 6533129 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-30 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-30 |
| 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, 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 489-0071 |
| Manufacturer Phone | 561485551 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, 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 NEUROVASCULAR GUIDE WIRE |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-04-30 |
| Returned To Mfg | 2017-04-06 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | UNK |
| 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, 489-0071 JA 489-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-30 |