MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE POLARIS X¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0047003D0

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for analysis.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

It was reported that the package was already opened.A 2.5/5/2.5mm/105cm polaris x was selected for use; however, it was noted that the packaging was already opened.The sterility of the product could not be verified.The catheter was not used.No patient complications were reported.

• Brand Name: POLARIS X¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 5270933
• MDR Text Key: 32792149
• Report Number: 2134265-2015-08468
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K003452
• 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: 11/10/2015

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: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: M0047003D0
• Device Catalogue Number: 7003D
• Device Lot Number: 18010198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2015
• 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