ULTRA ICE PLUS¿
Received Aug 15, 2017 · Event occurred Jul 14, 2017
Report 2134265-2017-07872 · MDR key 6795253
Device
Generic name
Catheter, Ultrasound, Intracardiac
Manufacturer
Boston Scientific - Costa Rica (coyol)Model number
M00499120Catalog number
9912
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pericardial Effusion
- Pericardial Effusion
Narrative
Additional Manufacturer Narrative
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT PATIENT PERICARDIAL EFFUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT AND LEFT ATRIUM. DURING AND ATRIAL FIBRILLATION ABLATION PROCEDURE AND ULTRA ICE PLUS¿ WAS USED. THE PHYSICIAN FELT THE ICE IMAGES HAD POOR QUALITY AND THE PHYSICIAN DESCRIBED THE PATIENT AS HAVING A THICK SEPTUM AND THOUGHT THAT MIGHT HAVE CONTRIBUTED TO THE POOR IMAGES. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED SURGICAL INTERVENTION. THEY ABORTED THE PROCEDURE DUE TO THIS EVENT. PATIENT IS NOW STABLE AND DOING WELL.