MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for STERLING 24690 manufactured by Boston Scientific Corporation.
[185940356]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[185940357]
It was reported that balloon rupture occurred. The 99% stenosed, target lesion was located in the mildly tortuous and severely calcified superficial femoral artery. A 6. 0mmx100mmx150cm sterling catheter was advanced for dilation. However, during the second inflation at 8 atmospheres in 10 seconds, the balloon ruptured. The procedure was completed with a different device. The device was completely removed without any issue noted. There no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04162 |
| MDR Report Key | 9904035 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-24 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2018-10-16 |
| 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 CORPORATION |
| 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 | STERLING |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | LIT |
| Date Received | 2020-03-31 |
| Model Number | 24690 |
| Catalog Number | 24690 |
| Lot Number | 0022801346 |
| 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 |