MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) LUGE¿; WIRE, GUIDE, CATHETER

Model Number H7491213001J2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: visual inspection howed the upn characteristics of this device were checked and effectively, it is design to use together with the magnet device.The device has the distal tip kinked.The device has the body broken approximately at 47 cm from the proximal end; the another returned section of wire measures approximately 135 cm from the distal tip.Also, it seems to be the broken section was kinked previous to be broken, due to both ends are bent.The overall length could not be performed due to device condition (body broken).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 13april2017.It was reported that magnet would not hold wire.A luge guidewire was selected for a angioplasty stent intervention however during the procedure doctor had the balloon in place, he was in the process of exchanging the balloon over the wire for a stent.In the process of removing the balloon using the magnet, the wire came back from across the lesion, wire position was not retained.The doctor removed the balloon and then used a rapid exchange system thereafter.They did not have to switch out to another magnet, the doctor refused to use another magnet.No complications to the patient, post procedure patient was stable.However analysis reveled that the guidewire was fractured.

• Brand Name: LUGE¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7484809
• MDR Text Key: 107283476
• Report Number: 2134265-2018-03835
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: H7491213001J2
• Device Catalogue Number: 12130-01J
• Device Lot Number: 0018583461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1