MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-11-17 for ASAHI CHIKAI 008 WAIN-CKI-008-200 manufactured by Asahi Intecc Co., Ltd..
[93311203]
(b)(4). Attempts were made to gather thorough event information during complaint processing; no further information could be obtained. The subject guide wire, including its separated distal segment approximately 9cm in length, and a concomitant microcatheter were returned. The guide wire was fractured at the end of the proximal solder. The fracture surface was uneven which suggested that the wire broke off due to repeated bending stress. Distal segment of the guide wire also had uneven fracture surface coincided with that of the proximal side. This inferred that the whole guide wire was retrieved. No other defect such as deformation that would affect wire slidability was observed. As for the concomitant microcatheter, its distal tube seemed somewhat stretched and slight deformation of the shaft tube that seemed associated with normal catheter usage was observed. No other damage was found on the microcatheter. Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received. There was no indication of product deficiency. Based on the provided information and the investigation outcome, it was presumed that repeated bending stress was assumed to be locally applied during wire manipulation while movement of the guide wire was temporally restricted possibly due to the size of the vessel, vessel tortuosity, and/or blood that entered into the concomitant microcatheter. When the bending stress exceeded the product's design limit, the guide wire eventually became fractured. Instructions for use states: - [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; - [precautions] if any resistance is felt during insertion into a catheter used with the guide wire, do not use it; - [precautions] do not repeatedly bend and stretch the same position of the guide wire, or continuously turn it in a curved vessel for a long period of time; and, - [malfunction and adverse effects] separation or breakage of the guide wire.
Patient Sequence No: 1, Text Type: N, H10
[93311204]
It was reported that during guidewire advancement within a non-asahi microcatheter, resistance was experienced. The guidewire was then removed from the microcatheter when it was noticed distal segment of guidewire missing. Under fluoroscopy, distal segment of guidewire was visualized inside the microcatheter. The microcatheter was removed from anatomy where distal segment of guidewire was then retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2017-00205 |
| MDR Report Key | 7043742 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-18 |
| Date of Event | 2017-11-06 |
| Date Facility Aware | 2017-11-07 |
| Report Date | 2017-11-08 |
| Date Reported to Mfgr | 2017-11-08 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2017-11-17 |
| 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 008 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-11-17 |
| Returned To Mfg | 2017-11-15 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-008-200 |
| Lot Number | 170722A52A |
| 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 | 2017-11-17 |