MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-08-31 for ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK 18 WAIN-CKI-18-200-BS manufactured by Asahi Intecc Co., Ltd..
[53662536]
Investigation of returned guidewire was made upon return of the device on 8/17, and it was found that the core wire had been pulled apart at approx. 13mm from tip, coil stretched for approx. 60cmm length and the plastic jacket over the coil was extended and damaged. During processing of this complaint, manufacturer attempted to obtain complete event and information. Lot history review revealed no anomaly relating to the reported event, no other similar product experience report was received. All the shipped product are inspected during the production process for meeting the product specifications and releasing criteria, based on the information reviewed, there is no indication of a product deficiency. Based on the obtained information and the outcomes of the investigation, it is presumed that the guidewire was inserted into the microcatheter before sufficiently wetting and flushing the guidewire surface and the catheter lumen, so that the guidewire lubricity by the hydrophilic polymer coating over the plastic jacket could not exert the lubricity, and/or the catheter lumen was temporally deformed due to the vessel running condition, causing the resistance in advancement of the guidewire. Along with the removal of the guidewire, force exceeding the product's design limit might be given to the guidewire, so that the core wire was pulled apart, coil and plastic jacket were stretched. Reportedly no complication is observed with the patient, however the whereabouts of the stretched broken fragment of the polymer jacket is not identified, it is highly supposed that the fragment might be left in the patient. The ifu describes as warnings: if any resistance is felt due to spasm or the guide wire being bent or trapped while operating the guide wire[? ]in the blood vessel or removing it, do not move or torque the guide wire. Stop the procedure. Determine the cause of resistance under fluoroscopy and take appropriate remedial action. If the guide wire is moved[? ]excessively, it may be damaged including separation or the like, which may cause blood vessel injury or result in fragments being left inside the vessel. As precautions: to exert the lubricity of the guide wire's surface, inject heparinized saline into the guide wire holder tube and the lumen of the catheter to be used before using the guide wire. Confirm that the whole surface is wet, then take out the guide wire, and insert it into the catheter. To prevent eventual thrombus caused by the manipulation of the catheter and the guide wire, flush the catheter lumen with heparinized saline or other suitable solution. And as possible malfunction and adverse effects: breakage or bending of the guide wire, damage such as separation, difficulty in removal, coming off of coating.
Patient Sequence No: 1, Text Type: N, H10
[53662537]
Reportedly in the revascularization procedure to the occlusive lesion at internal carotid artery, subject guidewire was used with other manufacturer's microcatheter, however the resistance was immediately felt when the guidewire was advanced into the concomitant microcatheter, and it was felt as if the guidewire was damaged. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[58159137]
Manufacturing site: asahi intecc hanoi co. , ltd. (b)(4), registration number: 3009121749.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003775027-2016-00149 |
| MDR Report Key | 5919846 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-08-31 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-07-28 |
| Date Mfgr Received | 2016-08-17 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-08-31 |
| 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 NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK 18 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2016-08-31 |
| Returned To Mfg | 2016-08-17 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-18-200-BS |
| Lot Number | 151016A28A |
| Device Expiration Date | 2018-09-30 |
| 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 | 2016-08-31 |