MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for BOSTON SCIENTIFIC NC QUANTUM APEX H7493912412300 manufactured by Boston Scientific Corp..
[185188791]
Nc quantum balloon unable to advance or be removed from prowater wire. Balloon shaft broke in half when trying to pull back. Distal end remained on wire. The broken balloon shaft and prowater wire with piece of pta balloon left on it were both removed from sterile field and delivered to our boss (b)(6). Boston sci rep (b)(6) was standing by at the time and will replace the balloon. Balloon was not actually in body when it broke. No harm to pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093918 |
| MDR Report Key | 9877774 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-04 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SCIENTIFIC NC QUANTUM APEX |
| Generic Name | CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS |
| Product Code | LOX |
| Date Received | 2020-03-24 |
| Model Number | H7493912412300 |
| Lot Number | 24618058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |