FDA Adverse Event Malfunction Summary report: N

INTELLAMAP ORION?

MDR report key: 24915997 · Received April 17, 2026

Report

Report Number: 2124215-2026-21032
Event Type: Malfunction
Date Received: April 17, 2026
Date of Event: April 9, 2026
Report Date: May 18, 2026
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: DRF
UDI-DI: 08714729841968
PMA / PMN Number: K143481
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

G4 PREMARKET / 510(K): K192360, K220796. 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE ORION CATHETER BECAME STUCK IN A BENT POSITION AND REMAINED BENT AFTER REMOVAL FROM THE BODY. DURING A REPEAT ATRIAL FIBRILLATION PROCEDURE TO TREAT PERI-MITRAL ATRIAL TACHYCARDIA (PERI-MI AT) IN THE LEFT ATRIUM, AN INTELLAMAP ORION CATHETER WAS SELECTED FOR USE. THE LEFT ATRIUM WAS MAPPED AND ENERGIZATION WAS PERFORMED. ENERGIZATION WAS DELIVERED INTO THE CORONARY SINUS; IT WAS THEN RETRACTED TO THE LEFT ATRIUM AND REPEATEDLY PERFORMING MAPPING DURING THE PROCEDURE. HOWEVER, THE ORION'S BENDING SUDDENLY GOT STUCK. DESPITE RETURNING THE CATHETER'S CURVE TO NEUTRAL, IT STILL REMAINED TILTED AT APPROXIMATELY 30 DEGREES. IN THAT STATE, IT WAS RETRACTED INTO THE SHEATH AND THE CATHETER WAS THEN REPLACED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WILL NOT RETURN FOR ANALYIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
136903	INTELLAMAP ORION?	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING	DRF	BOSTON SCIENTIFIC CORPORATION	M004RC64S0	0038133730	08714729841968

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown