MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-02 for ATLANTIS SR (IVWS) C4020 H749C40200 manufactured by Boston Scientific Scimed.
[217083]
Intracoronary ultrasound catheter broke off in pt. Snare guided in and retrieved it. (tip broke off. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022978 |
| MDR Report Key | 354486 |
| Date Received | 2001-10-02 |
| Date of Event | 2001-09-05 |
| Date Added to Maude | 2001-10-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATLANTIS SR (IVWS) |
| Generic Name | ULTRASOUND CATHETER |
| Product Code | ITY |
| Date Received | 2001-10-02 |
| Model Number | C4020 |
| Catalog Number | H749C40200 |
| Lot Number | 3513739 |
| ID Number | * |
| Device Expiration Date | 2001-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 343707 |
| Manufacturer | BOSTON SCIENTIFIC SCIMED |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-10-02 |