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

Model Number	85056
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure using a blazer ii htd catheter to treat paroxysmal supraventricular tachycardia [psvt] the displayed temperature did not increase during ablation.They first replaced the cable, however, the issue was not resolved.They then replaced the catheter and were able to complete the procedure without patient complications.The catheter is expected to be returned for analysis.
Additional Manufacturer Narrative
The device was received at boston scientific's post market laboratory for analysis.Upon receipt the catheter was visually inspected and no eternal damage or abnormalities were found.Next the device was functionally tested which revealed that the steering knob and tension control knobs behaved correctly in both the locked and unlocked positions.Additionally, no resistance was felt when actuating the steering mechanism.Finally the device was electrically tested and the results were found to be within specification and no opens or shorts were found.It was concluded that the catheter did not present any evidence of the reported issue nor any defect that could have contributed to this event, therefore, the reported complaint was not confirmed by analysis.In addition, a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported that during a procedure using a blazer ii htd catheter to treat paroxysmal supraventricular tachycardia [psvt] the displayed temperature did not increase during ablation.They first replaced the cable, however, the issue was not resolved.They then replaced the catheter and were able to complete the procedure without patient complications.The catheter has been returned for analysis.

• 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: 11935357
• Report Number: 2134265-2021-07227
• Device Sequence Number: 19791079
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: 08714729172048
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 08/07/2023
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0025828904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR