MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

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

Patient Problem Ischemia Stroke (4418)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that on (b)(6) 2021 an ventricular tachycardia ablation procedure was completed with a intellanav mifi open-irrigated ablation catheter and intellamap orion high resolution mapping catheter.Two days following the procedure the patient experienced a stroke on (b)(6) 2021.Blurring in the left eye was observed and no intervention was noted.The cause of the stroke is unknown to the physician.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Additional information added to b5.

Event Description

It was reported that on (b)(6) 2021 an ventricular tachycardia ablation procedure was completed with a intellanav mifi open-irrigated ablation catheter and intellamap orion high resolution mapping catheter.Two days following the procedure the patient experienced a stroke on (b)(6) 2021.Blurring in the left eye was observed and no intervention was noted.The cause of the stroke is unknown to the physician.Additional information received indicated that the suspected cause of the stroke was due to 2 non-boston scientific sheaths.After the first sheath failed, a second sheath was prepped on the table.During preparation, it began to crack as the dilator was inserted.The second sheath was exchanged and the procedure resumed with another sheath from a different manufacturer.The procedure was successful with the patient leaving the room with no complications.The patient is almost fully recovered at the most recent follow-up and is expected to fully recover.The physician did not attribute the event to any of the boston scientific products.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• 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: 11862968
• MDR Text Key: 251927254
• Report Number: 2134265-2021-06646
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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 Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/24/2021
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Patient Outcome(s): Other