MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-15 for ULTRA ICE PLUS? M00499120 9912 manufactured by Boston Scientific - Costa Rica (coyol).
[82723601]
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).
Patient Sequence No: 1, Text Type: N, H10
[82723602]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-07872 |
| MDR Report Key | 6795253 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-15 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA ICE PLUS? |
| Generic Name | CATHETER, ULTRASOUND, INTRACARDIAC |
| Product Code | DXK |
| Date Received | 2017-08-15 |
| Model Number | M00499120 |
| Catalog Number | 9912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-15 |