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	Fever (1858); Unspecified Infection (1930)
Date of Event	11/22/2019
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
Clinical study (b)(6).It was reported the patient experienced a fever and infection.On (b)(6) 2019, after an ablation procedure with an intellanav mifi open-irrigated ablation catheter, an intellamap orion high resolution mapping catheter, two ep-xt diagnostic catheters and two non-boston scientific sheaths, the patient experienced a high fever and was diagnosed with an ambiguous infection.The patient was given unacid 3g intravenously (iv) on (b)(6) 2019, cefirexon 2g iv on (b)(6) 2019 and zopiclon 7.5mg orally on (b)(6) 2019.The event resolved on (b)(6) 2019.

• 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: 9756638
• Report Number: 2134265-2020-02144
• Device Sequence Number: 2185547
• 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
• Report Date (Section B): 02/26/2020

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: 09/13/2022
• Device Model Number: 86716
• Device Catalogue Number: 86716
• Device Lot Number: 0024432103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 100