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 Display or Visual Feedback Problem (1184)

Patient Problem Pericardial Effusion (3271)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

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 pulmonary vein insolation procedure to treat a paroxysmal atrial fibrillation, an intellamap orion catheter was selected for use.Once the orion catheter was placed inside of the body, it was not able to visualize deployment on the mapping system; however, it was possible to see signals, and deployment was confirmed on fluoroscopy.In order to solve the issue, catheter connection cable was replaced, but the issue persisted.Catheter was replaced and the issue was resolved.The new catheter smoothly went through the transseptal after exchanging it.Physician started mapping and then noticed a pericardial effusion.The procedure had been taking place for about 30 minutes.A pericardiocentesis was done, but no further knowledge of any other interventions is known.The patient was stable upon leaving the procedure room, further information about patient condition is not known.Initial procedure was cancelled due to the pericardial effusion.

Event Description

It was reported that during a pulmonary vein insolation procedure to treat a paroxysmal atrial fibrillation, an intellamap orion catheter was selected for use.Once the orion catheter was placed inside of the body, it was not able to visualize deployment on the mapping system; however, it was possible to see signals, and deployment was confirmed on fluoroscopy.In order to solve the issue, catheter connection cable was replaced, but the issue persisted.Catheter was replaced and the issue was resolved.The new catheter smoothly went through the transseptal after exchanging it.Physician started mapping and then noticed a pericardial effusion.The procedure had been taking place for about 30 minutes.A pericardiocentesis was done, but no further knowledge of any other interventions is known.The patient was stable upon leaving the procedure room, further information about patient condition is not known.Initial procedure was cancelled due to the pericardial effusion.

Manufacturer Narrative

Correction section f10 and h6 impact codes updated from f1901: additional surgery to f23: unexpected medical intervention 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 d4 lot number lot number 0030789061 unique identifier (udi) # (b)(4).Intellamap orion high resolution mapping catheter was evaluated by boston scientific.Visual inspection noted the device does not have visual defects.Electrical test did not identify any shorts or opens.Also, device was recognized by rhythmia and showed no issue during mapping or deployment.A functional test was performed and the steering knob and the tension control knob functioned properly on both lock and unlock positions.Deployment slider functioned properly, and the basket shape was formed.No abnormal resistance was felt when executing the steering mechanism and deployment system.Laboratory analysis was unable to confirm the reported clinical observations.Device was found within specifications.

Event Description

It was reported that during a pulmonary vein insolation procedure to treat a paroxysmal atrial fibrillation, an intellamap orion catheter was selected for use.Once the orion catheter was placed inside of the body, it was not able to visualize deployment on the mapping system; however, it was possible to see signals, and deployment was confirmed on fluoroscopy.In order to solve the issue, catheter connection cable was replaced, but the issue persisted.Catheter was replaced and the issue was resolved.The new catheter smoothly went through the transseptal after exchanging it.Physician started mapping and then noticed a pericardial effusion.The procedure had been taking place for about 30 minutes.A pericardiocentesis was done, but no further knowledge of any other interventions is known.The patient was stable upon leaving the procedure room, further information about patient condition is not known.Initial procedure was cancelled due to the pericardial effusion.

• 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: 16952923
• MDR Text Key: 315462760
• Report Number: 2124215-2023-23402
• 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,Followup,Followup
• Report Date: 08/30/2023

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
• Device Lot Number: 0030789061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 05/05/2023; 08/09/2023
• Supplement Dates FDA Received: 05/31/2023; 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention