MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE CONSTELLATION®; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

Model Number M004US8060U0

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

It was reported that a spline retraction issue occurred.The target lesion was located in the atrium.A constellation® was selected to treat the lesion.During procedure, it was noted that out of 8 splines, one of the 8 splines/wires that form the basket would not collapse back.The procedure was completed.There were no patient complications reported and the patient's status was fine.

Manufacturer Narrative

Age at time of event: over 18 years of age.(b)(4).

Manufacturer Narrative

Device evaluated by mfr., the device has been returned for analysis.Overall visual inspection did not identify failures or evidence that could be lost due to decontamination process.The device does not have visual defects, all the splines meet the manufacturing requirements and the basket deploy and retract properly.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is not confirmed.(b)(4).

Event Description

It was reported that a spline retraction issue occurred.The target lesion was located in the atrium.A constellation was selected to treat the lesion.During procedure, it was noted that out of 8 splines, one of the 8 splines/wires that form the basket would not collapse back.The procedure was completed.There were no patient complications reported and the patient's status was fine.

• Brand Name: CONSTELLATION®
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4332732
• MDR Text Key: 5141330
• Report Number: 2134265-2014-08101
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2015
• Device Model Number: M004US8060U0
• Device Catalogue Number: US8060U
• Device Lot Number: 15843434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2013
• 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