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	11/02/2017
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 device was not returned for analysis.Investigation of the production record could not be performed as the lot information was unavailable.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with heavy calcification in the distal right coronary artery (rca).The asahi gaia guide wire was advanced but could not cross the lesion due to the anatomy and became stuck in the calcified vessel.During the attempt to withdraw the guide wire, the tip of the guide wire snapped.Due to the vessel calcification, there was no attempt to retrieve the separated tip of the guide wire and the procedure was stopped.The separated guide wire tip remains stuck in the calcification.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was 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: 7053120
• Report Number: 3003775027-2017-00214
• Device Sequence Number: 13725876
• Product Code: DQX
• UDI-Device Identifier: 04547327094788
• UDI-Public: 04547327094788
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 11/22/2017

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 Catalogue Number: AHW14R011P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/22/2017
• 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
• Patient Age: 41 YR