MAUDE Adverse Event Report: AV-ASAHI ASAHI GAIA PTCA GUIDE WIRE

Catalog Number	AHW14R011P
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The analysis was performed by asahi intecc.Co.Ltd: 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.Torquing or pushing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation or direct damage to a vessel.Although device investigation could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of product deficiency.(b)(4).
Event or Problem Description
It was reported that during an intervention in the very calcified, chronic total occlusion (cto) in the right coronary artery, the gaia third guide wire was used with a corsair catheter.The gaia third wire was advanced 3/4 of the way into the mid to distal rca when the physician pulled the corsair catheter back.It was then noted that the gaia third guide wire separated.The physician suspects that the tip of the corsair catheter got stuck to the gaia third guide wire.Unsuccessful attempts were made to snare the separated wire.The patient was taken to surgery, but the wire could not be surgically removed, so it was cut leaving about 6 cms of the wire in the cto artery.The rca was bypassed as percutaneous intervention was unsuccessful in opening the cto.There was no reported adverse patient sequela or a clinically significant delay in procedure.There was no additional information provided.

• Brand Name: ASAHI GAIA PTCA GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-ASAHI; asahi intecc co. ltd med div; 3-100 akatsuki-cho; seto 489-0 071; JA 489-0071
• MDR Report Key: 6745633
• Report Number: 3003775027-2017-00137
• Device Sequence Number: 1161548
• Product Code: DQX
• UDI-Device Identifier: 04547327094788
• UDI-Public: 04547327094788
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: AHW14R011P
• Device Lot Number: 161102A071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/26/2017
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR
• Patient Weight: 116