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

Model Number 86716

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Pleural Effusion (2010); Pneumonia (2011); Heart Failure (2206); Complaint, Ill-Defined (2331)

Event Date 01/21/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9878896
• MDR Text Key: 187083775
• Report Number: 2134265-2020-03868
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877578
• UDI-Public: 08714729877578
• Combination Product (y/n): N
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/21/2020
• Patient Sequence Number: 1
• Treatment: 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.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70