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 Bradycardia (1751); Embolism/Embolus (4438)

Event Date 03/23/2023

Event Type  Injury  

Event Description

It was reported that during a redo pulmonary vein isolation (pvi) procedure, a boston scientific device was selected for use.Arrhythmia map suggested either a cavo-tricuspid isthmus-dependent atrial flutter (at) with a breakthrough near to the slow-path region/cs latium or a focal at from this region.Ablation here caused a prolongation of the pq interval, but the procedure was completed.After the procedure was done the patient did not wake up even after propofol was turned off.Mri will be performed to check for the patient's health.A solid embolus unrelated the ep consumables was suspected.Further non-ablation intervention will be done for patient safety.It is unknown if the device will be returned.The ablation catheter used in the procedure was not identified, a intellanav oi device was used to capture the unknown ablation device.

Manufacturer Narrative

The ablation catheter used in the procedure was not identified, a intellanav oi device was used to capture the unknown ablation device.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Additional information added to event description and subsequent updates to suspect medical device as result of the additional information provided.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a redo pulmonary vein isolation (pvi) procedure, an intellamap orion high resolution mapping catheter (orion) was selected for use.A rhythmia map suggested either a cavo-tricuspid isthmus-dependent atrial flutter (at) with a breakthrough near to the slow-path region/cs latium or a focal at from this region.Ablation here caused a prolongation of the pq interval, but the procedure was completed.After the procedure was done the patient did not wake up even after propofol was turned off.Mri will be performed to check for the patient's health.A solid embolus unrelated the ep consumables was suspected.Further non-ablation intervention will be done for patient safety.It is unknown if the device will be returned.Additional information received indicated that none of the devices had an impact on the case outcome or patient complication, the prolongation of the pq interval was an undesired consequence of the ablation performed.No other interventions to the patient took place.It was not possible to confirm if an embolism caused the patient complications.After the procedure, the patient was fine after the ablation and woke up after a few hours.It is unknown if the patient got a pacemaker or if the pq interval recovered to normal.The orion catheter was the only device information provided by the field.

• 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: 16664211
• MDR Text Key: 312520733
• Report Number: 2124215-2023-15357
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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 Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention