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

Model Number	87120
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Mitral Perforation (2512)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on all available information boston scientific was not able to establish the cause for the mitral valve damage reported by the field.The device was not returned for analysis, and insufficient information was provided to confirm the event or determine a cause.A manufacturing documentation review was performed, and no abnormalities were discovered.
Event or Problem Description
It was reported that during a radio frequency ablation procedure to treat wolff-parkinson-white the patient's mitral valve was damaged.During the procedure there was difficulty moving the catheter through the patient's anatomy.A chorda tendineae rupture of the mitral valve occurred when they attempted to forcefully remove the catheter.Surgery was performed to repair the damage and a mitral valve replacement was performed.The patient was hospitalized for three weeks following the surgery.Per the physician, there was no issue or defect with the catheter.The catheter had been caught in the chorda tendineae of the mitral valve due to positioning of the device during the procedure.The catheter is not expected to be returned as it was disposed of after the procedure.

• Brand Name: BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER
• Common Device Name: 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: 18275129
• Report Number: 2124215-2023-68496
• Device Sequence Number: 19639670
• Product Code: LPB
• UDI-Device Identifier: 08714729803614
• UDI-Public: 08714729803614
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2026
• Device Model Number: 87120
• Device Catalogue Number: 87120
• Device Lot Number: 0031574585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown