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 2019-05-07 for OCCLUDER M0062201090 220-109 manufactured by Boston Scientific Corporation.
[144272278]
(b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[144272279]
This report pertains to one of two occlusion balloon catheters used in the same patient and procedure. It was reported to boston scientific corporation that two occlusion balloon catheters were used in the ureter during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the balloon burst. The same issue occurred with the second occlusion balloon catheter. The procedure was completed with another occlusion balloon catheter. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02391 |
| MDR Report Key | 8586323 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-07 |
| Date of Report | 2019-08-13 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-07-23 |
| Device Manufacturer Date | 2019-01-11 |
| Date Added to Maude | 2019-05-07 |
| 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 | OCCLUDER |
| Generic Name | CATHETER, UROLOGICAL |
| Product Code | EYB |
| Date Received | 2019-05-07 |
| Model Number | M0062201090 |
| Catalog Number | 220-109 |
| Lot Number | 0023173580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-07 |