MAUDE Adverse Event Report: AV-ASAHI ASAHI CONFIANZA PRO PTCA GUIDE WIRE

Catalog Number	20629-02
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2016
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 (b)(4): although device investigation of the confianza could not be conducted, since all the shipped products are inspected in the production process for meeting the product specifications and release criteria, there is no indication of a product deficiency.The warnings section of the instructions for use: states, if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire.Lot history review revealed no anomaly relating to the reported event and no other similar product experience reports were received.Based on the obtained information, the investigation determined the difficulties to be related to circumstances of the procedure.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left superficial femoral artery.The tip of the confianza pro guide wire broke off inside the patient's leg.No attempts were made to retrieve the separated segment.The patient has been discharged.No additional information was provided.

• Brand Name: ASAHI CONFIANZA PRO 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: 6153213
• Report Number: 3003775027-2016-00221
• Device Sequence Number: 16163624
• Product Code: DQX
• UDI-Device Identifier: 04547327055819
• UDI-Public: (01)04547327055819(17)181130(10)151218A071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2016

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: 11/30/2018
• Device Catalogue Number: 20629-02
• Device Lot Number: 151218A071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2016
• Initial Report FDA Received Date: 12/07/2016
• 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: 62 YR