MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-06 for ULTRA ICE PLUS? M00499120 9912 manufactured by Boston Scientific - Costa Rica (coyol).
[101634879]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101634880]
It was reported that device packaging was compromised. During unpacking of the ultra ice plus? Imaging catheter a 1 cm slit was found in the part where it will be opened. No patient involvement as the device could not be delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-01394 |
| MDR Report Key | 7315860 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-06 |
| Date of Report | 2018-02-07 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2017-11-16 |
| Date Added to Maude | 2018-03-06 |
| 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 | 2018-03-06 |
| Returned To Mfg | 2018-03-02 |
| Model Number | M00499120 |
| Catalog Number | 9912 |
| Lot Number | 0021395014 |
| Device Expiration Date | 2019-11-16 |
| 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 | 2018-03-06 |