MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-26 for ASAHI CHIKAI BLACK 14 AIN-CKI-200-B-SFT manufactured by Asahi Intecc Co., Ltd..
[106586180]
(b)(4). This report is for the second guide wire used in the same procedure reported under mfr report #: 3003775027-2018-00090. Attempts were made to gather thorough event information during complaint processing; no further information could be obtained. Device investigation could not be performed because the device was not returned. Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received for this lot. Reviewing of the manufacturing records confirmed no indication of product deficiency. Due to limited information and as device investigation could not be performed, involvement of the subject guide wire to the reported bleeding could not be ascertained; therefore, a possibility that the guide wire might cause or contribute to the reported bleeding could not be completely ruled out. Malfunctions and adverse effects section of the instructions for use (ifu) states bleeding complications.
Patient Sequence No: 1, Text Type: N, H10
[106586181]
It was reported that small bleeding occurred after a procedure to treat an aneurysm where an asahi guide wire was used. Reportedly no additional intervention was performed against this bleeding. The patient had been under a routine outpatient monitoring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2018-00091 |
| MDR Report Key | 7463591 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2018-04-26 |
| 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 | ASAHI CHIKAI BLACK 14 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2018-04-26 |
| Model Number | NA |
| Catalog Number | AIN-CKI-200-B-SFT |
| Lot Number | 170522A16A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-26 |