MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M0042011010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiac Tamponade (2226)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
Ot was reported that following a procedure using a dynamic xt steerable diagnostic catheter the patient experienced cardiac tamponade.The procedure had been completed successfully and while in the recovery area the patient became tachycardic, hypotensive, and diaphoretic.An echo was performed, and tamponade was identified.A pericardiocentesis was performed and the effusion was resolved.The patient was admitted overnight for observation and discharged the following day.They are expected to make a full recovery.The cause of the effusion could not be determined.The catheter is not available for return as it was disposed of after the procedure was completed.
Additional Manufacturer Narrative
Udi related data quality updates only: this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
Ot was reported that following a procedure using a dynamic xt steerable diagnostic catheter the patient experienced cardiac tamponade.The procedure had been completed successfully and while in the recovery area the patient became tachycardic, hypotensive, and diaphoretic.An echo was performed, and tamponade was identified.A pericardiocentesis was performed and the effusion was resolved.The patient was admitted overnight for observation and discharged the following day.They are expected to make a full recovery.The cause of the effusion could not be determined.The catheter is not available for return as it was disposed of after the procedure was completed.

• Brand Name: DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 18187358
• Report Number: 2124215-2023-65422
• Device Sequence Number: 6541683
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: (01)08714729877615(17)20260810(10)0032199978
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K921872
• 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,Followup
• Report Date (Section B): 07/22/2024

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: 08/10/2026
• Device Model Number: M0042011010
• Device Catalogue Number: 86706
• Device Lot Number: 0032199978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER; INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown