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); ST Segment Elevation (2059)

Event Date 10/16/2019

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.Lot number was not provided; therefore, a ship history of previous lots sent to the customer was reviewed.Device history record (dhr) review of the lots identified found no issues.

Event Description

It was reported that the patient experienced hypotension and st segment elevation.During a redo pulmonary vein isolation (pvi), the physician obtained left atrium (la) access via a non-boston scientific (bsc) tran-septal needle and directional sheath.The intellamap orion high resolution mapping catheter was then advanced into the la via the sheath.The physician was not satisfied with the location of the tran-septal puncture, so the orion intellamap catheter was completely removed from the patient and the sheath was withdrawn back into the right atrium (ra).While the sheath was being positioned for a second transeptal attempt, the patient developed st segment elevation on the surface electrocardiogram (ecg) and the arterial blood pressure dropped significantly.An urgent echocardiogram was then completed and there were no signs of pericardial effusion.The procedure was cancelled and the patient left the electrophysiology (ep) lab in stable condition.The physician commented at the time that the cause may have been from the non-bsc directional sheath and was unrelated to bsc product.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 9311809
• MDR Text Key: 166050703
• Report Number: 2134265-2019-13724
• Device Sequence Number: 1
• Product Code: DRF
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

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: 10/16/2019
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ABBOTT MEDICAL TRAN-SEPTAL NEEDLE; AGILIS SHEATH
• Patient Outcome(s): Other
• Patient Age: 75 YR