MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for OCCLUDER M0062201090 61095 manufactured by Boston Scientific Corporation.
[122170207]
(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
[122170208]
It was reported to boston scientific corporation that an occluder balloon catheter was used in the kidney during a percutaneous nephrolithotomy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, the balloon would not stay inflated. Reportedly, the balloon had a pinhole. The procedure was continued using the deflated balloon and the procedure was completed at this time there were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60610 |
| MDR Report Key | 7913978 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2018-09-27 |
| 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 | 0 |
| Brand Name | OCCLUDER |
| Generic Name | CATHETER, UROLOGICAL |
| Product Code | EYB |
| Date Received | 2018-09-27 |
| Model Number | M0062201090 |
| Catalog Number | 61095 |
| Lot Number | 0022412066 |
| Device Expiration Date | 2019-12-23 |
| 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 | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |