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

Catalog Number	AHW14R001S
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Ventricular Tachycardia (2132)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number: (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: device investigation could not be conducted as it was not available.It was presumed that torsion exceeding the products design limit might be inadvertently applied to the guide wire along with manipulation while it was trapped by the deployed stent.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.[malfunction and adverse effects] separation or breakage of the guide wire.The device is manufactured by asahi intecc.Co.Ltd.(b)(4), registration number: (b)(4).(b)(4) distributes the device and is responsible for mdr reporting.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the right coronary artery that was previously lined with stents (full metal jacket).During advancement, the asahi sion 180cm guide wire became stuck and the tip separated between two previously implanted stents.The separated segment was embedded in the vessel as it was stented over.The patient went into ventricular tachycardia with defibrillation performed.It is unknown if the ventricular tachycardia is related to the event.The pacemaker was removed and a balloon pump placed.As of (b)(6) 2017, the patient is stable.No adverse patient sequelae.There was no clinically significant delay.No additional information was provided.

• Brand Name: ASAHI SION 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: 6906057
• Report Number: 3003775027-2017-00178
• Device Sequence Number: 891567
• Product Code: DQX
• UDI-Device Identifier: 04547327082624
• UDI-Public: 04547327082624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100578
• 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): 09/29/2017

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: AHW14R001S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 09/29/2017
• 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
• Patient Age: 58 YR
• Patient Weight: 87