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 2019-05-13 for SEAL BIOPSY VALVE manufactured by Boston Scientific Corporation.
[144840247]
The complainant was unable to provide the event/procedure date, therefore the first day of the month in which the event was reported was used (b)(6) 2019). The complainant was unable to provide the suspect device upn and lot number as the device is part of a compliance kit; therefore, the expiration date, device manufacture dates, udi, and model number are unknown. (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
[144840248]
It was reported to boston scientific corporation that a seal biopsy valve was used on an unknown date. According to the complainant, the seal biopsy valves is leaking. It was not reported how the procedure was completed. There was no serious injury nor adverse patient effects reported as a result of this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available; a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02454 |
| MDR Report Key | 8603947 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-13 |
| 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 | 2019-05-13 |
| 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 | 2019-05-13 |