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 Chest Pain (1776); Tissue Damage (2104)

Event Date 02/20/2020

Event Type  Injury  

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 Description

It was reported that the patient experienced tissue damage.After an premature ventricular ectopy ablation procedure with an intellamap orion high resolution mapping catheter, the patient experienced a mediastinal thermal injury post ablation.During the procedure, radiofrequency (rf) ablation was delivered to the distal coronary sinus (cs) and the adjacent right ventricular outflow tract (rvot).There were no issues during the procedure.Upon discharge, the patient reported chest pain and a computed tomography (ct) chest scan was performed.A mediastinal thermal injury was reported.The orion catheter was left in the descending aorta during ablation.The catheter was disposed of and was therefore not being returned.No device performance issues were reported.

Event Description

It was reported that the patient experienced tissue damage.After an premature ventricular ectopy ablation procedure with an intellamap orion high resolution mapping catheter, the patient experienced a mediastinal thermal injury post ablation.During the procedure, radiofrequency (rf) ablation was delivered to the distal coronary sinus (cs) and the adjacent right ventricular outflow tract (rvot).There were no issues during the procedure.Upon discharge, the patient reported chest pain and a computed tomography (ct) chest scan was performed.A mediastinal thermal injury was reported.The orion catheter was left in the descending aorta during ablation.The catheter was disposed of and was therefore not being returned.No device performance issues were reported.It was further reported that no interventions were performed to resolve the event and the patient has recovered.It was further reported that there was no noise on the ablation catheter.During ablation, there was an impedance change of about 20 ohms, to a max of 27 ohms, correlating to lesion sets in the cs and rvot.

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 the patient experienced tissue damage.After an premature ventricular ectopy ablation procedure with an intellamap orion high resolution mapping catheter, the patient experienced a mediastinal thermal injury post ablation.During the procedure, radiofrequency (rf) ablation was delivered to the distal coronary sinus (cs) and the adjacent right ventricular outflow tract (rvot).There were no issues during the procedure.Upon discharge, the patient reported chest pain and a computed tomography (ct) chest scan was performed.A mediastinal thermal injury was reported.The orion catheter was left in the descending aorta during ablation.The catheter was disposed of and was therefore not being returned.No device performance issues were reported.It was further reported that no interventions were performed to resolve the event and the patient has recovered.

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.

• 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: 9885062
• MDR Text Key: 187706589
• Report Number: 2134265-2020-03941
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0024235946
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 04/05/2020; 05/06/2020
• Supplement Dates FDA Received: 04/23/2020; 05/20/2020
• 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
• Patient Age: 62 YR