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 2019-04-30 for UROMAX ULTRA KIT M0062251210 225-121 manufactured by Boston Scientific Corporation.
[143681351]
(b)(4). Investigation results: visual examination of the returned complaint device revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure. Functional analysis was performed, and the balloon was inflated; however, the balloon would not hold pressure due to a pinhole located at the centre of the distal markerband. This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the manner in which the device was handled, the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon, and/or the interaction between the scope and the balloon. 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. A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label.
Patient Sequence No: 1, Text Type: N, H10
[143681352]
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, it was noticed that the balloon had a hole when tried to be inflated. The procedure was completed with another uromax ultra dilatation balloon catheter device. 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 | 3005099803-2019-02241 |
| MDR Report Key | 8566328 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2019-03-07 |
| Date Added to Maude | 2019-04-30 |
| 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 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 | UROMAX ULTRA KIT |
| Generic Name | DILATOR, CATHETER, URETERAL |
| Product Code | KOE |
| Date Received | 2019-04-30 |
| Returned To Mfg | 2019-04-01 |
| Model Number | M0062251210 |
| Catalog Number | 225-121 |
| Lot Number | 0023448968 |
| 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 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-30 |