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 2020-03-31 for SYNERGY 10607 manufactured by Boston Scientific Corporation.
[185942636]
It was reported that the stent was stripped off from the balloon. The target lesion was in the coronary artery. A 3. 00x38 synergy drug eluting stent and a guidezilla ii guide extension catheter were selected for use in a percutaneous coronary intervention (pci). During the procedure, it was noted that the stent was stripped off from the balloon at the collar of the guidezilla. The stent delivery system was then removed to the collar of the guidezilla and were removed together. However, a crack at the collar of the guidezilla was noted after removal. There were no device fragments left inside the patient's body and the procedure was completed with a different device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04099 |
| MDR Report Key | 9903237 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-09-03 |
| Date Added to Maude | 2020-03-31 |
| 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 IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGY |
| Generic Name | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Model Number | 10607 |
| Catalog Number | 10607 |
| Lot Number | 0024416686 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-31 |