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 2020-03-25 for HURRICANE RX M00545900 4590 manufactured by Boston Scientific Corporation.
[185485353]
(b)(4). A visual examination of the returned complaint device found that the inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge but none of them showed abnormalities. No damages were found in the device. Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole leak located near the distal end of the ro marker. This failure is likely due to factors or conditions related to the procedure during the use of the device, such as the manner in which the device was handled and manipulated, the technique used by the physician during the procedure, and the interaction between the scope and device, that could have affected its performance and its intended purpose. Therefore, the most probable root cause is adverse event related to procedure. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Patient Sequence No: 1, Text Type: N, H10
[185485374]
This report pertains to one of three hurricane rx dilatation balloons used during the same procedure. It was reported to boston scientific corporation that three hurricane rx dilatation balloons were used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, it was noted that the balloon leaked. The same issue occurred with the second and third hurricane rx dilatation balloons. The procedure was completed with a fourth hurricane rx balloon. There were no patient complications reported as a result of this event. Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01208 |
| MDR Report Key | 9881124 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-11-04 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | CORK BUSINESS TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HURRICANE RX |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | FGE |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-01-31 |
| Model Number | M00545900 |
| Catalog Number | 4590 |
| Lot Number | 0024706744 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |