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

Model Number	85056
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the blazer ii catheter was received and inspected, it was noted that there was a problem with the labeled upn in (b)(6).The upn from factory is m0045031th0 but the upn on (b)(6) label is m0044500th0.There was no patient involvement.The device has been returned to boston scientific and is pending analysis.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection was performed.A cardboard box was received for this complaint.The box was in good condition and no damages were observed.The labels looked good, legible and without damages.The box had attached to its surface a label in chinese language (attached after it left the manufacturing floor) and it was encountered that the universal part number (upn) printed on it did not matched with the upn printed on the original label.Media inspection was also performed.The customer attached a picture where was possible to observe the cardboard box of a blazer ii htd device.The parts of the box observed in the image looked in good condition, without damages.The labels were legible and without damages.The only issue observed was the upn printed on the label in chinese language; it did not match with the upn reported for this complaint and printed on the label of the box.No more visual defects were observed through the photo sent by the customer.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that when the blazer ii catheter was received and inspected, it was noted that there was a problem with the labeled upn in chinese.The upn from factory is m0045031th0 but the upn on chinese label is m0044500th0.There was no patient involvement.The device has been returned to boston scientific and analysis has been completed.

• Brand Name: BLAZER II HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11556182
• Report Number: 2134265-2021-03756
• Device Sequence Number: 17155741
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: 08714729172048
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 10/09/2023
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0026162278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1