MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-26 for GLADIUS MG14 PV PP14R203P manufactured by Asahi Intecc Co., Ltd..
[188207469]
(b)(4). The gladius mg14 pv missing its tip was returned for evaluation. The distal segment of the returned guide wire was three-dimensionally deformed. The polymer jacket and the coil wire were fractured at the same location, exposing the fractured core wire. For observation purposes, the polymer jacket was removed. The fracture end of the core wire was located at approximately 20mm distal to the mid solder that was originally located at 27mm from the tip. The fractured end of the coil wire was located at approximately 15mm distal to the mid solder. Observation by scanning electron microscope was performed on the fracture end. It revealed that there were circumferential cracks on the core wire shaft proximal to its fracture end, indicating repeated bending stress had applied on the core wire. The core fracture end was smaller than the original size of the core, suggesting tensile stress had also applied on the core wire. The fracture end of the coil wire showed a flat fracture surface, one of characteristics found on fracture by torsion that had likely generated as coils were being pulled and straightened. Above findings supported that the reported guide wire was missing approximately 7mm of the core wire and approximately 15mm of coils with underlying inner coils. 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 presumed that repeated bending stress had most likely contributed to the observed fracture of the core wire. The accumulated bending stress would exceed the product design limit when the guide wire was being trapped and its movement was restricted by the lesion. Further applied tensile stress generated with removal had caused the coil wire to be pulled apart with the inner coil wire. It was concluded that this event was not attributed to product quality. Instructions for use (ifu) states: [warnings] observe movement of this guide wire in the vessels. Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy. Do not move or torque the guide wire without observing corresponding movement of the tip. In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire; [warnings] never push, auger, withdraw, or torque a guide wire that meets resistance. Torquing or pushing a guide wire against resistance may cause guide wire damage and/or guide wire tip separation or direct damage to a vessel. Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire tip. If guide wire tip prolapse is observed, do not allow the tip to remain in a prolapsed position. [otherwise damage to the guide wire 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] separation of the guide wire.
Patient Sequence No: 1, Text Type: N, H10
[188207470]
It was reported that the tip of an asahi gladius mg14 pv guide wire broke off during a ppi to treat a heavily calcified cto in the right external iliac artery. The guide wire was used to cross the lesion when its tip became trapped and fractured. Another guide wire was delivered parallel to the fractured guide wire in attempts to retrieve; however, the attempt failed. The physician decided to leave the wire fragment in situ and terminated the procedure. Blood flow was successfully reestablished by bypass grafting. The physician commented that calcification of the lesion was so heavy that the wire tip became trapped as it was pushed into the lesion. The patient was fined without problem after the bypass surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2020-00060 |
| MDR Report Key | 9881906 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-26 |
| 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 | GLADIUS MG14 PV |
| Generic Name | PERIPHERAL GUIDE WIRE |
| Product Code | DQX |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-13 |
| Model Number | NA |
| Catalog Number | PP14R203P |
| Lot Number | 190808A221 |
| 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. Deathisabilit | 2020-03-26 |