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 2017-12-27 for 3.3 MM X 403 MM ULTRASOUND PROBE M0068407160 840-716 manufactured by Boston Scientific - Spencer.
[95829524]
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[95829525]
Note: this manufacturer report pertains to one of two devices used in the same procedure. Refer to the associated manufacturer report 3005099803-2017-03909 for the other associated device information. It was reported to boston scientific corporation on (b)(6) 2017 that two ultrasound probes were used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017. According to the complainant, during the procedure, ten minutes into the procedure, the first ultrasound probe (the subject of this mfr report) broke in half when the lithoclast was at level 90. The same issue happened with the second ultrasound probe (mfr report #3005099803-2017-03909). The broken pieces were retrieved from inside the patient with the use of a grasper. The procedure was successfully completed using another of the same device and also a holmium laser. 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 good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-03908 |
| MDR Report Key | 7148066 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-07 |
| Device Manufacturer Date | 2017-09-28 |
| Date Added to Maude | 2017-12-27 |
| 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 | 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 | 3.3 MM X 403 MM ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2017-12-27 |
| Model Number | M0068407160 |
| Catalog Number | 840-716 |
| Lot Number | 21188293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2017-12-27 |