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 2019-04-04 for OCCLUDER M0062201090 220-109 manufactured by Boston Scientific Corporation.
[140921266]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[140921267]
It was reported to boston scientific corporation that an occluder ballon catheter was used in a procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the balloon burst.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01610 |
| MDR Report Key | 8483233 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-04 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-05-20 |
| Device Manufacturer Date | 2018-12-05 |
| Date Added to Maude | 2019-04-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-04-04 |
| Returned To Mfg | 2019-04-15 |
| Model Number | M0062201090 |
| Catalog Number | 220-109 |
| Lot Number | 0023035830 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-04 |