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 2016-02-10 for 3.8 MM X 403 MM ULTRASOUND PROBE M0068407170 840-717 manufactured by Boston Scientific - Spencer.
[37975101]
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
[37975102]
It was reported to boston scientific corporation that an ultrasound probe was opened for used in a percutaneous nephrolithotomy procedure on (b)(6) 2016. According to the complainant, during the preparation of the procedure, it was noticed that the seal was not adhering and was rendered to be compromised. 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
[40152619]
Analysis of the returned device found the pouch seal open starting at the chevron end, and peeled to approximately 49. 5 cm from the chevron end. The remaining portion of the seal remained intact. The visual evaluation of the pouch seal also revealed that it had been properly formed and no voids were present. Analysis of the returned device showed no evidence of the alleged issue or any other defect, therefore; the most probable root cause could not be confirmed. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.
Patient Sequence No: 1, Text Type: N, H10
[40152621]
It was reported to boston scientific corporation that an ultrasound probe was opened for used in a percutaneous nephrolithotomy procedure on (b)(6) 2016. According to the complainant, during the preparation of the procedure, it was noticed that the seal was not adhering and was rendered to be compromised. 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 | 3005099803-2016-00337 |
| MDR Report Key | 5427380 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-10 |
| Date of Report | 2016-01-13 |
| Date of Event | 2016-01-13 |
| Date Mfgr Received | 2016-02-23 |
| Device Manufacturer Date | 2015-07-22 |
| Date Added to Maude | 2016-02-10 |
| 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 |
| 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 | 3.8 MM X 403 MM ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2016-02-10 |
| Returned To Mfg | 2016-01-20 |
| Model Number | M0068407170 |
| Catalog Number | 840-717 |
| Lot Number | 18217618 |
| Device Expiration Date | 2018-07-31 |
| 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 | 2016-02-10 |