MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-25 for STERLING 24716 manufactured by Boston Scientific Corporation.
[185033458]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[185033459]
It was reported that balloon rupture occurred. The totally occluded target lesion was located in the mildly tortuous and severely calcified superficial femoral artery and below the knee vessel. A 2. 0x220x150 (4f) sterling balloon catheter was advanced for dilatation. However, during inflation at nominal atmospheres, the balloon ruptured. The device was simply pulled out and completely removed. The procedure was completed with another of the same device. No patient complications were reported and the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03834 |
| MDR Report Key | 9878812 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-11-05 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | 24716 |
| Catalog Number | 24716 |
| Lot Number | 0024713042 |
| 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 | 2020-03-25 |