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 2019-05-03 for SEAL BIOPSY VALVE SBC-580-100 2095-02 manufactured by Boston Scientific Corporation.
[143964258]
The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). According to the complainant is not available for return; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143964259]
It was reported to boston scientific corporation that a seal biopsy valve was used on an unknown date. According to the complainant, during the procedure, the biopsy cap popped off from the biopsy port of the scope causing fluids to spray everywhere. They were able to complete the case with this device. There was no serious injury nor any adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02322 |
| MDR Report Key | 8577746 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-05-03 |
| 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 | NOLATO CONTOUR INC |
| Manufacturer Street | 660 VANDEBERG STREET , |
| Manufacturer City | BALDWIN WI 54002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEAL BIOPSY VALVE |
| Generic Name | BIOPSY VALVE |
| Product Code | OCX |
| Date Received | 2019-05-03 |
| Model Number | SBC-580-100 |
| Catalog Number | 2095-02 |
| 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 | 2019-05-03 |