MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008

Catalog Number	WAIN-CKI-008-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.Although attempts were made to gather thorough event information during complaint processing, no further information could be obtained.The returned guidewire was observed.There was no notable abnormality or deformity found on the guidewire.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the provided information and the investigation outcome, it was concluded that the returned chikai 008 guidewire had no notable abnormality that affected the wire lubricity.Stuck occurred between the guidewire and the microcatheter was thought to be related to vessel tortuosity, vessel circumflex, and/or blood that entered into the microcatheter that temporarily restricted the wire lubricity.Reported abnormality found approximately 3-5cm proximal to the distal tip was not found on the guidewire; it was perhaps the middle solder that looked like a marker band.It was presumed that unraveling of the embolization coil occurred during removal of the devices while the distal end of the guidewire or the catheter was trapped by the coil; however, which device contributed to unraveling of the coil could not be determined.The warnings section of the ifu states: 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 move or torque the device without observing corresponding movement of the tip.Otherwise, the device may be damaged and/or vessel trauma may occur.In addition, ensure that the distal tip of this device and its location in the vessel are visible during manipulations of the device; never push, auger, withdraw, or press this device with enough force to feel resistance.Pressing or pushing this device against resistance may cause damage and/or tip separation of this device or direct damage to a vessel.Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the tip of the device.If the prolapse of the device tip is observed, do not allow the tip to remain in a prolapsed position.Otherwise damage to the device may occur.Determine the cause of resistance under fluoroscopy and take any necessary remedial action; and, 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.
Event or Problem Description
During avm embolization, an asahi guidewire was used with a 1.3 fr.Microcatheter (manufacturer unknown).When the guidewire was advanced inside the avm followed by the microcatheter, the guidewire would not advance nor retract inside the microcatheter so that both devices were removed simultaneously from the lesion.Upon removal from the lesion, under fluoroscopy, a loop of coil was inadvertently removed from the previously embolized lesion along with the guidewire and microcatheter.An irregular contour or a bulbous segment was observed on the guidewire approximately 3-5cm proximal to the distal tip (as if the guidewire itself had a marker band around the wire).The coil loop was left in place and procedure was halted.There was no health impact on the patient.

• Brand Name: ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008
• Common Device Name: NEUROVASCULAR GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 6337985
• Report Number: 3003775027-2017-00019
• Device Sequence Number: 11039159
• Product Code: MOF
• UDI-Device Identifier: 04547327098120
• UDI-Public: (01)04547327098120(17)190930(10)161019A04A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2017
• Report Date (Section F): 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: WAIN-CKI-008-200
• Device Lot Number: 161019A04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other