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 Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure to treat atrial fibrillation (afib), an intellamap orion catheter was selected for use, and a non-boston scientific sheath (12 fr) was used for mapping in the left atrium.The versacross access system was used for guidewire and transseptal access.There was possible resistance when upsizing from the versacross to a non-boston scientific device.After this, while mapping the left atrium, low pressures and drop in end tidal were noted.The issue occurred during mapping.Therefore, the kit used during transseptal puncture could not be linked to the issue observed.Later on, it was discovered that the patient was in pulseless electrical activity (pea).The procedure was cancelled, compressions were started and a pericardiocentesis was performed when the pressures were better.The patient was taken to the operating room for surgical repair of a perforation near the left atrial appendage (laa).The patient was intubated but the repair was deemed successful.The patient fully recovered with zero deficits, the boston scientific devices were disposed at the facility.

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.

• 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
• 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: 16808495
• MDR Text Key: 313937146
• Report Number: 2124215-2023-18190
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2023

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: 02/22/2024
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0030008073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 77 YR