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

Model Number H74912130012

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-11599, 2134265-2016-11600 and 2134265-2016-11606.It was reported that guide wire fracture, target vessel flow occlusion, chest pain and st segment elevation occurred.The target lesion was located in a heavily calcified with several tortuous bends in the proximal to mid right coronary artery (rca).After placing a 182cm luge¿ guide wire and 6fr guide catheter, the lesion was pre-dilated with a 2.5x15 nc emerge balloon catheter.A 2.5x20 synergy drug-eluting stent (des) was then advanced but failed to cross the lesion.The device was removed and a 6fr non-bsc guide extension catheter was then advanced through the non-bsc guide catheter.The 2.5x20 synergy des was re-advanced and was deployed in the mid rca with no issue.A 2.5x16 synergy des was then deployed to the proximal rca however the stent failed to fully expand.The luge¿ guide wire was removed from the coronary artery to have a better injection of the rca and it was decided to post dilate the 2.5x16 synergy des with a 3.0x8 nc emerge balloon catheter.The luge¿ guide wire was reinserted however, the device failed to cross lesion and the previously deployed stent in the mid rca.The 3.0x8 nc emerge balloon catheter was not advanced to the lesion and upon removing of the device, the guide catheter tapped backwards into the aortic arch and the luge¿ guide wire broke 3 cm from the radiopaque portion.Upon examination, injection and re-entry in the guide catheter, it was noted that the rca had closed off.The patient experienced moderate chest pain and st segment elevation was noted.Attempts in rewiring the stent and the distal vessel failed and the patient then undergone coronary artery bypass graft (cabg).The rca was re-vascularized via a vein graft to the distal rca and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• 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: 6173447
• MDR Text Key: 62338111
• Report Number: 2134265-2016-11399
• 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: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: H74912130012
• Device Catalogue Number: 12130-01
• Device Lot Number: 0019538081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2.5X16 SYNERGY STENT; 2.5X20 SYNERGY STENT; 3.0X8 NC EMERGE BALLOON CATHETER; 6F FFR4 GUIDE CATHETER; 6F GUIDELINER
• Patient Outcome(s): Required Intervention