MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-17 for ASAHI CHIKAI 10 WAIN-CKI-10-300 manufactured by Asahi Intecc Co., Ltd..
[31357677]
(b)(4). Reportedly the device in question will be available. An investigation into the event as well as the report timing is ongoing. A supplemental report will be submitted once the returned device analysis is completed. Regarding the timing of the report, a review of the complaint reporting process from the distributors is underway. We will implement appropriate corrective actions to prevent recurrence.
Patient Sequence No: 1, Text Type: N, H10
[31357678]
During guidewire advancement/ maneuvering inside superficial temporal artery(sta), reportedly physician noticed no movement of distal of the guidewire. Upon removal of the guidewire from anatomy, it was found that the distal portion of the guidewire was missing from proximal segment of guidewire. The distal potion of the guidewire was found inside the sta by fluoroscopic observation.
Patient Sequence No: 1, Text Type: D, B5
[33978466]
(b)(4). Device was returned to manufacturer on (b)(6) 2015. Inspection of the returned device revealed its core wire was broken off at 67mm from tip end, trace of continuous clockwise rotation was observed at the broken end of the core wire. Coil wire was entirely removed from the returned device and missing. At the proximal brazing, broken coil wire end was found deformed toward outward. Broken portion was not returned. Lot history review revealed no anomaly relating to the reported event, no other similar product experience report was received. Asahi intecc products are inspected as part of the production process, and must meet their product specification criteria prior to final release. There were no anomalies found in the final release record for the lot involved in this reported event and no indication of product deficiency. Based on the inspection of returned device, it is inferred that the guidewire distal end might be trapped in the vessel, where rotational manipulation was made, core wire was broken off when the accumulated rotational force exceeded the product design limit, coil wire might be elongated and twisted off at its proximal brazing point. Ifu describes in warning section : -if any resistance is felt due to spasm or the device being bent or trapped while operating the device in the blood vessel or removing it, do not move or torque the device. Stop the procedure. Determine the cause of resistance under fluoroscopy and take appropriate remedial action. If the device is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel. -when torquing this device inside the blood vessel, do not torque continuously in the same direction it may be damaged or break apart, which may injure the blood vessel or leave fragments inside the vessel when torquing the device, rotate it clockwise and counterclockwise alternately do not exceed two rotations in the same direction. This supplemental report adds details regarding the receipt of the original information from the importer (section f). The original information was received by the initial importer on (b)(6) 2015, but not transmitted to the manufacturer until (b)(6) 2015. The initial mdr report was submitted by the manufacturer on (b)(6) 2015, prior to the receipt of the product on (b)(6) 2015. The initial mdr report was submitted by the manufacturer within 30 days of receipt of the information from the initial importer. Single reporter exemption (b)(4) was granted to allow a single report by the manufacturer. A review of prior events from this and other distribution sites indicates that this delay in reporting is isolated. All other events have been reported to the manufacturer within the 30-day limit. The initial importer has taken corrective actions, including hiring of additional staff. In addition, retraining of existing staff and distributors is ongoing to emphasize the importance of timely transmission of any potentially reportable event.
Patient Sequence No: 1, Text Type: N, H10
[58155269]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003775027-2015-00129 |
| MDR Report Key | 5229316 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-17 |
| Date of Report | 2016-09-23 |
| Date of Event | 2015-09-24 |
| Date Mfgr Received | 2015-11-19 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-11-17 |
| 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 | MS. YUKAKO HOMMA |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 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, 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 10 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2015-11-17 |
| Returned To Mfg | 2015-11-19 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-10-300 |
| Lot Number | A131212A73A |
| Device Expiration Date | 2016-11-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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, 4890071 JA 4890071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-11-17 |