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

Model Number 85020

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

It was reported that foreign material was found inside the packaging.During preparation when they opened the blazer catheter, they found that the package contained dirt/trash inside the bag.Another of the same device was used to complete the procedure.No patient complication occurred.

Event Description

It was reported that feorgin material was found inside the packaging.During preparation when they opened the blazer catheter, they found that the package contained dirt/trash inside the bag.Another of the same device was used to complete the procedure.No patient complication occurred.

Manufacturer Narrative

The visual inspection revealed that a blazer device was returned with its original opened box, its pouch was returned sealed.There was a foreign matter near the proximal side of the device.The foreign matter moves freely within the sealed pouch.The foreign matter was compared against a size estimation tappi chart and it is bigger than the black comparation dot of 1.00 square millimeters.

• Brand Name: BLAZER II
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9385150
• MDR Text Key: 174381896
• Report Number: 2134265-2019-14563
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729199939
• UDI-Public: 08714729199939
• Combination Product (y/n): N
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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: 09/17/2021
• Device Model Number: 85020
• Device Catalogue Number: 85020
• Device Lot Number: 0022668708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1