MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2016-01-19 for ASAHI CHIKAI 200CM WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[36204953]
Single reporter exemption #(b)(4). The incident information was provided by medical device company of the medical device that was used in the same procedure where asahi guidewire was used. The guidewire was not returned to manufacturer for analysis. During processing of this event information, attempts were made to obtain complete event, patient and device information. However, no information in addition to those provided from the said medical device company could be obtained. Reportedly, the physician commented that relation between the vessel perforation and the microcatheter, retriever device and guidewire could not be deniable. Lot history review could not be done since no lot information was available, while all the shipped products are inspected in the production process for meeting the products specifications and release criteria, there is no indication of a product deficiency. Based on the provided information, no perforation was observed while slight leakage of contrast media was seen, detail of the event could not be revealed. Warning section of ifu describes; "always advance and withdraw the device slowly. " "observe movement of this device in the vessels. Before this device is moved or torqued, the tip movement should be examined and monitored under fluoroscopy. " "do not push the device more than necessary to advance the tip through the narrowed part of the vessel. " "damage to a vessel, including possible vessel perforation" is described as ones of possible adverse events.
Patient Sequence No: 1, Text Type: N, H10
[36204954]
For the procedure to vasculogenic vessel occlusion at m1 of right mca, merci microcatheter and the subject guidewire were advanced. Then, thrombectomy was performed once using merci retriever device, however during this operation, cerebral bleeding with symptomatic device- related perforation was observed. Three hours after the procedure, the pt's exhibited lowering of consciousness level, left hand paralysis, pupil no movement, and the pt went coma. Craniotomy under low pressure and retrieval of the hematoma was performed. Pt recovered the health condition and was discharged from the hospital on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2016-00006 |
| MDR Report Key | 5375717 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2016-01-19 |
| Date of Report | 2015-12-22 |
| Date of Event | 2012-12-11 |
| Date Mfgr Received | 2015-12-22 |
| Date Added to Maude | 2016-01-19 |
| 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 | EIICHI KUBO |
| Manufacturer Street | 3-100 AKATSUKI-CHO, |
| Manufacturer City | SETO, 4890071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 4890071 |
| Manufacturer Phone | 561485551 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100, AKATSUKI-CHO, |
| Manufacturer City | SETO, 4890071 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 4890071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI CHIKAI 200CM |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2016-01-19 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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, 4890071 JA 4890071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2016-01-19 |