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 2020-03-26 for MUSTANG 24674 manufactured by Boston Scientific Corporation.
[185209017]
It was reported that balloon rupture occurred. Vascular access was obtained via contralateral approach. The 95% stenosed target lesion was located in the moderately tortuous and severely calcified right common iliac artery to external iliac artery. After a guidewire crossed the lesion, intravascular ultrasound was performed. A 8. 0mmx20mmx135cm sterling balloon catheter was advanced for pre-dilatation. However, upon inflation at 8 atmospheres, the balloon ruptured. The device was replaced with a 8. 0 x 40, 40cm mustang balloon catheter but it also ruptured during inflation at 10 atmospheres. Subsequently, three epic stents were implanted and post-dilatation was performed with a 8x60 sterling balloon catheter. The procedure was completed and no patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03546 |
| MDR Report Key | 9884056 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-09-12 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | MUSTANG |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | FGE |
| Date Received | 2020-03-26 |
| Model Number | 24674 |
| Catalog Number | 24674 |
| Lot Number | 0022645526 |
| 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 | 2020-03-26 |