MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 87121

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned therefore based on the information provided the most probable cause of the reported issue cannot be established due to s lack of evidence.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.The dhr review was performed and no related deviations within manufacturing processes were found, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.

Event Description

It was reported that the package was not sealed properly.Before an ep study procedure a blazer prime htd catheter was selected for use.The staff opened the box and took out the item and realized the package was open from the bottom end.Therefore, the product was not sealed properly thus not sterile.The catheter was changed, and the procedure was successfully completed without patient complication.

• Brand Name: BLAZER PRIME HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10276918
• MDR Text Key: 198917496
• Report Number: 2134265-2020-09374
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: 87121
• Device Catalogue Number: 87121
• Device Lot Number: 0024655475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1