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 2020-03-27 for EMERGE 7135 manufactured by Boston Scientific Corporation.
[185547374]
It was reported that catheter entrapment occurred. The target lesion was located in a left coronary artery. After a 300cm non-bsc support guidewire crossed the lesion, a 4. 00mm x 30mm emerge balloon catheter was advanced for dilatation. However, during withdrawal, the balloon could not move without moving the wire. The procedure was completed with a different device. No patient complications nor injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03780 |
| MDR Report Key | 9889520 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-27 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC SCIMED, INC |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMERGE |
| Generic Name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Product Code | LOX |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 7135 |
| Catalog Number | 7135 |
| Lot Number | 0023180988 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |