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

Catalog Number	AHW14R004J
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
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).Investigation of the device could not be conducted as it was not returned.Investigation of the production records for the device could not be performed as no lot information was available.Based on the provided information, it is presumed that pulling force exceeding the products design limit might be inadvertently given to the subject guide wire while its tip was trapped by the lesion or narrowed part of the vasculature, stretching the coil.Although the device investigation and lot history review could not be conducted, there was no indication of product deficiency since all the shipped products are inspected in the production process and satisfied the product specifications and release criteria.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The device is manufactured by (b)(4); however, the manufacturing site could not be determined because the product lot number was not provided.Abbott vascular 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 pulmonary artery.Resistance was felt during removal of the guide wire from the anatomy which resulted in the tip coils of the guide wire stretching.No core separation was observed.Another guide wire was used successfully for the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI SION BLUE 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: 7182823
• Report Number: 3003775027-2018-00011
• Device Sequence Number: 73035
• Product Code: DQX
• UDI-Device Identifier: 04547327086240
• UDI-Public: 04547327086240
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AHW14R004J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1