ULTRA ICE PLUS
Received Apr 14, 2020 · Event occurred Feb 1, 2020
Report 2134265-2020-05058 · MDR key 9957114
Device
Generic name
Catheter, Ultrasound, Intracardiac
Manufacturer
Boston Scientific CorporationModel number
86200Catalog number
86200
Lot number
0023798185
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Chest Pain
- Chest Pain
Narrative
Additional Manufacturer Narrative
WEIGHT: (B)(6). 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
INTERRUPT AF CLINICAL STUDY. FOLLOWING AN ABLATION PROCEDURE WITH AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, TWO ULTRA ICE PLUS CATHETERS, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER AND A POLARIS X STEERABLE DIAGNOSTIC CATHETER, THE PATIENT WAS HOSPITALIZED DUE TO A COMPLAINT OF CHEST PAIN. THE PATIENT WAS GIVEN INTRAVENOUS (IV) FUROSEMIDE 40MG, METHYLPREDNISOLONE (SOLU-MEDROL) 125MG AND LORAZEPAM (ATIVAN) 0.5MG AND THE EVENT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.