MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-17 for ASAHI CHIKAI WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[114279432]
(b)(4). The guide wire and its fragment were returned for evaluation. The distal segment of the returned guide wire was deformed into a loop at approximately 130 mm from the solder set at 300 mm proximal to the tip. At approximately 160 mm distal to the solder, the core wire was found fractured. At approximately 12 mm distal to the core fracture end, the coil wire was found fractured. The fracture end of the core wire was flat, suggesting torsion was generated as the coils got straightened. The core fracture was microscopically observed. It found that the core wire was sharply bent and demonstrated a flat fracture surface. Observation by a scanning electron microscope (sem) revealed a trace of fracture by bending and torsional stress. The returned wire fragment was undulated. It was bent in a u-shape at the proximal end. The coils were stretched for approximately 25 mm and then fractured. As seen on the proximal side of coil fracture, the fracture end was flat; it suggested that coil wire became fractured by torsion generated as coils got straightened. To observe the core underneath, coils were intentionally unraveled. The core was found fractured at approximately 140 mm from the wire tip. Sem observation revealed a trace of fracture by bending and torsional stress, as seen on the proximal side of fracture. By measuring the core length of the returned wire and its fragment, it was concluded that the entire wire was returned. Lot history review revealed no anomaly relating to the reported event. No other similar product experience report was received for this lot. Based on the obtained information and investigation outcome, it was concluded that bending stress with torsion that exceeded the product's design limit was inadvertently applied as the wire was assumed to be prolapsed by wire manipulation that might be affected by vessel condition, causing the core to become fractured. The coils were assumed to be stretched and eventually separated upon wire removal. There was no indication of product deficiency. Instructions for use (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; and, [malfunction and adverse effects] breakage or bending of the guide wire.
Patient Sequence No: 1, Text Type: N, H10
[114279433]
It was reported that an asahi guide wire became separated during embolization of the moderately tortuous occipital artery to treat a brain tumor. When the guide wire was used with a balloon catheter, the physician felt resistance as if the guide wire was being stuck. Then he attempted to remove it from the anatomy when the distal segment of the guide wire broke off. The separated tip was retrieved by using a gooseneck snare. The procedure was presumed with a new guide wire. The intended treatment was successfully completed with no patient injury or problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2018-00141 |
| MDR Report Key | 7697043 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-06-25 |
| Device Manufacturer Date | 2018-05-14 |
| Date Added to Maude | 2018-07-17 |
| 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 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2018-07-17 |
| Returned To Mfg | 2018-06-28 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | 180503A30A |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2018-07-17 |