MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-10-28 for ASAHI CHIKAI BLACK 18 WAIN-CKI-18-200-BS manufactured by Asahi Intecc Co., Ltd..
[29786221]
Single reporter exemption (b)(4). Investigation of returned device revealed abrasive damage with the polymer jacket. Reported black material was also returned, and was supposed to be the abraded polymer coating. Reportedly there was no impact to the patient. Lot history review revealed no anomaly relating with the reported event. With the outcomes of the investigation, it is inferred that the guidewire might be abraded by inserter tool or alike during use, and the polymer coating was partly scraped by the edge of the tool, found at the y-connector of the catheter. All the products are inspected in the production process for meeting the product specifications and shipping criteria. Based on the obtained information there is no indication of a product deficiency. Ifu describes: never us metallic needles or metallic sheaths for insertion and withdrawal of this device. Otherwise the surface of this device may be damaged significantly.
Patient Sequence No: 1, Text Type: N, H10
[29786222]
Reportedly, during use of subject guidewire for the procedure to neurological artery, physician observed some black material at the y-connector of the catheter used in combination. Reportedly there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[58167444]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003775027-2015-00116 |
| MDR Report Key | 5186280 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-10-28 |
| Date of Report | 2016-09-23 |
| Date of Event | 2015-09-30 |
| Date Mfgr Received | 2015-10-01 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-10-28 |
| 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 BLACK 18 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2015-10-28 |
| Returned To Mfg | 2015-10-08 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-18-200-BS |
| Lot Number | 150129A01B |
| Device Expiration Date | 2018-12-31 |
| 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 | 2015-10-28 |