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 2018-03-22 for ULTRA ICE PLUS? M00499120 9912 manufactured by Boston Scientific - Costa Rica (coyol).
[103289246]
Age at time of event : over 18 years. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103289247]
It was reported that the a foreign substance was noted. An ultra ice plus imaging catheter was selected for use. During preparation, it was noted that the sterile water injected to the tip of the catheter looked cloudy. Furthermore, the device was inserted to the patient's body but physician discontinued the usage and removed the device from the patient. The procedure was completed with another of the same device. No patient complications were reported and the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-02275 |
| MDR Report Key | 7362456 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-22 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2017-07-14 |
| Date Added to Maude | 2018-03-22 |
| 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 | 2018-03-22 |
| Returned To Mfg | 2018-03-15 |
| Model Number | M00499120 |
| Catalog Number | 9912 |
| Lot Number | 20881358 |
| Device Expiration Date | 2019-07-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-22 |