MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) CONSTELLATION®; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

Model Number M004US8038U0

Device Problem Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Unit was received for analysis after decontamination (in appropriate packaging).The returned device matches the upn and lot number provided by the customer.Microscopic inspection shows body fluid on multiple electrode rings and a blue material that looks to be protruding out from underneath an electrode ring on a spline in the distal basket which is located on spline #8 ¿ b2.This blue material is most likely a part of the tip sheath (blue cover, which collapses the basket.) electrical test was performed.Every electrode on all 8 splines were observed and confirmed to have the correct connection to the corresponding leds on the electrical test box.No opens or shorts were encountered.Complaint stated noise was observed on b3-4, so there is no indication that this blue material which is located on spine 8 ¿ b2 is the direct cause of the reported noise.There was no indication that analysis results were affected by the decontamination process.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based on device analysis completed 7-aug-2017.It was reported that noise occurred.A constellation catheter was advanced and was being used during an atrial fibrillation ablation case, when noise appeared on b3-4.The cable was exchanged; however, the noise persisted.The lab pin box was exchanged; however, the noise persisted.The user elected to remove b3-4 from the screen and the procedure was able to be completed with this device.No patient complications nor patient injury was reported.However, returned device analysis revealed foreign material.

• Brand Name: CONSTELLATION®
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• 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: 6776964
• MDR Text Key: 82173283
• Report Number: 2134265-2017-08366
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• PMA/PMN Number: K983171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2018
• Device Model Number: M004US8038U0
• Device Catalogue Number: US8038U
• Device Lot Number: 18219002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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