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

Model Number	86716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Pleural Effusion (2010); Pneumonia (2011); Heart Failure (2206); Complaint, Ill-Defined (2331)
Date of Event	01/21/2020
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
(b)(6) clinical study.It was reported that the patient experienced pneumonia, "cardial decomposition," pain in the lower stomach, ascites and pleural effusion following an ablation procedure with an intellanav mifi open-irrigated ablation catheter, an intellamap orion high resolution mapping catheter, a tsx fixed curve sheath, an ep-xt diagnostic catheter and a non-boston scientific steerable introducer.The patient was given intravenous or intramuscular antibiotics and the event resolved.The suspected cause was exertional dyspnea after ablation.
Event or Problem Description
Localize pm007 clinical study.It was reported that the patient experienced pneumonia, "cardial decomposition," pain in the lower stomach, ascites and pleural effusion following an ablation procedure with an intellanav mifi open-irrigated ablation catheter, an intellamap orion high resolution mapping catheter, a tsx fixed curve sheath, an ep-xt diagnostic catheter and a non-boston scientific steerable introducer.The patient was given intravenous or intramuscular antibiotics and the event resolved.The suspected cause was exertional dyspnea after ablation.It was further reported that the device would not be returned because there was no technical failure observed during the procedure.At the time the event started, the patient was already released from the hospital.
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.

• Brand Name: EP XT
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9878896
• Report Number: 2134265-2020-03868
• Device Sequence Number: 3183379
• Product Code: DRF
• UDI-Device Identifier: 08714729877578
• UDI-Public: 08714729877578
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 06/27/2022
• Device Model Number: 86716
• Device Catalogue Number: 86716
• Device Lot Number: 0024030903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER.; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER.; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER.; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER.; ST JUDE MEDICAL AGILIS NXT.; ST JUDE MEDICAL AGILIS NXT.; TSX FIXED CURVE SHEATH.; TSX FIXED CURVE SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70