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 2017-07-10 for 1.0 MM X 570 MM RIGID PNEUMATIC PROBE M0068407330 840-733 manufactured by Boston Scientific - Spencer.
[79515449]
(b)(4). The device has been received for analysis; however the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[79515450]
It was reported to boston scientific corporation on (b)(6) 2017 that a rigid pneumatic probe was opened on an unknown date. According to the complainant, when the device was taken out of the box, there was a tear in the bottom of the packaging that compromised the sterility of the probe. The probe was not used in the procedure therefore, no patient complications have been noted as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02032 |
| MDR Report Key | 6696848 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-10 |
| Date of Report | 2017-06-14 |
| Date Mfgr Received | 2017-08-15 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2017-07-10 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.0 MM X 570 MM RIGID PNEUMATIC PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2017-07-10 |
| Returned To Mfg | 2017-06-23 |
| Model Number | M0068407330 |
| Catalog Number | 840-733 |
| Lot Number | 20322218 |
| 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 - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |