MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI FIELDER XT; PTCA GUIDE WIRE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device evaluation could not be performed because the device was discarded by the facility.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for this lot.Reviewing of manufacturing records found no indication of product quality deficiency.Based on the obtained information and referring to known similar incidents, it was presumed that tensile stress repeatedly applied on the guide wire in attempts to remove exceeded the product's design limit as the wire tip was being trapped in the severely tortuous, severely calcified occlusion.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: (warnings) if any resistance is felt due to spasm or the guide wire being bent or trapped while operating the guide wire in the blood vessel or removing it, do not move or torque the guide wire.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; and, (malfunction and adverse effects) separation of the guide wire.
Event or Problem Description
It was reported that the intervention was to treat a severely tortuous, severely calcified 100% occlusion in the left peroneal artery.After directing the guide wire and a non-asahi micro catheter to the proximal cap of the lesion, multiple attempts were made to traverse the co cap after which the wire and micro catheter became lodged in the calcific burden.Multiple attempts were made to withdraw the wire and micro catheter at which time the tip of the micro catheter and wire detached in the calcific cap.The remaining micro catheter and wire were removed and a snare was used to attempt to retrieve the wire and micro catheter tips at which time the loop of the snare became lodged and broke off in the calcium as well.It was determined at that time to stop the case.It was the physician's decision that the patient's condition was not any worse that when he went in for the procedure as he already had no flow.
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 FIELDER XT
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 8913714
• Report Number: 3003775027-2019-00142
• Device Sequence Number: 11451317
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861(17)220331(10)190415A031
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K072431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: AGP140302
• Device Lot Number: 190415A031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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: Disability