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 2016-12-01 for 3.3 MM X 330 MM ULTRASOUND PROBE M0068407140 840-714 manufactured by Boston Scientific - Spencer.
[61237831]
(b)(4). The device has been received for analysis. 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
[61237832]
It was reported to boston scientific corporation that a lithoclast ultrasound probe was used for a percutaneous nephrolithotomy procedure on (b)(6) 2016. According to the complainant, during the procedure, the probe broke in two pieces and fell inside the patient? S anatomy. The physician retrieved the broken pieces with an instrument. A radiogram (x-ray) was performed to confirm there were pieces left inside the patient. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event and the patient? S condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[63225525]
Visual analysis of the returned lithoclast ultrasound probe revealed that the device was broken at 4. 7cm from the hub. The probe working length was free of obvious kinks and bends. The probe presents signs of oxidation in some areas and an examination of the device found areas of heavy surface scratches in several locations along the probe working length. Due to the heavy scratches in several locations the most probable root cause is user/use error. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications. A labeling review was performed and no anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
[63225526]
It was reported to boston scientific corporation that a lithoclast ultrasound probe was used for a percutaneous nephrolithotomy procedure on (b)(4) 2016 according to the complainant, during the procedure, the probe broke in two pieces and fell inside the patient? S anatomy. The physician retrieved the broken pieces with an instrument. A radiogram (x-ray) was performed to confirm there were pieces left inside the patient. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event and the patient? S condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-03784 |
| MDR Report Key | 6138840 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2016-12-15 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2016-12-01 |
| 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 |
| Manufacturer G1 | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.3 MM X 330 MM ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2016-12-01 |
| Returned To Mfg | 2016-11-30 |
| Model Number | M0068407140 |
| Catalog Number | 840-714 |
| Lot Number | 18646982 |
| Device Expiration Date | 2018-11-30 |
| 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 | 1. Required No Informationntervention | 2016-12-01 |