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

Model Number	85020
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9385150
• Report Number: 2134265-2019-14563
• Device Sequence Number: 2207631
• Product Code: LPB
• UDI-Device Identifier: 08714729199939
• UDI-Public: 08714729199939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1