MAUDE Adverse Event Report: ASAHI INTECC USA, INC. ASAHI FIELDER XT; WIRE, GUIDE, CATHETER

Catalog Number AGP140002

Device Problems Fracture (1260); Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

During left heart catheterization, physician used a fielder xt wire and the 1.25 x 8 mm rapid exchange trek balloon for back up support.With the balloon in the midportion of the vessel prior to the stenosis, he was able to get better support and pushability and able to cross the lesion and then place the wire in the distal right coronary artery (rca), albeit with resistance from the heavily calcified stenosis.He then was able to telescope the balloon across into the lesion segment and multiple inflations up to 20 atmospheres were performed again in an attempt to create a micro channel through the stenosis.The balloon was withdrawn and an angiogram was performed.He then pulled back the fielder xt wire in attempt to reposition the wire in the distal runoff vessels.Upon pulling back the wire, the distal tip of the wire remained in the distal vessel.The wire shaft apparently became separated and the wire that is coiled around the central shaft remained intact, however.They could see the radiopacification of the distal wire past the lesion segment.Attempts to retrieve the wire were unsuccessful secondary to the high-grade stenosis.

• Brand Name: ASAHI FIELDER XT
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC USA, INC.; 2500 red hill ave #210; santa ana CA 92705
• MDR Report Key: 4534670
• MDR Text Key: 5508835
• Report Number: 4534670
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2015

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
• Device Operator: Invalid Data
• Device Catalogue Number: AGP140002
• Device Lot Number: 140120A182
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2015
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 74