MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,company representati report with the FDA on 2015-06-18 for 3.8 MM X 403 MM ULTRASOUND PROBE M0068407170 840-717 manufactured by Boston Scientific - Spencer.
[20808924]
It was reported to boston scientific corporation that an ultrasound probe was used on a procedure on an unknown date. According to the complainant, the probe broke in half during use. 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
[21072348]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (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
[32011926]
A visual examination confirmed that the returned device was broken approximately 5. 4 cm from the hub; the probe did not present any bending. The user had placed three black marks near the hub on the side opposite to the etched marks. An examination of the fracture surfaces revealed areas that appear to have received excessive heating prior to breakage. The device surface presented areas of heavy scratches; 2cm long near the tip and another at 27-28cm from tip. The reported complaint of probe broken was confirmed according to product condition. Without additional information and due to the probable excessive heating prior to breakage, the most probable root cause is use/user error.
Patient Sequence No: 1, Text Type: N, H10
[32011927]
It was reported to boston scientific corporation that an ultrasound probe was used on a procedure on an unknown date. According to the complainant, the probe broke in half during use. 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 | 3005099803-2015-01780 |
| MDR Report Key | 4853082 |
| Report Source | 00,01,07,COMPANY REPRESENTATI |
| Date Received | 2015-06-18 |
| Date of Report | 2015-05-29 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-06-18 |
| 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 | 2015-06-18 |
| Returned To Mfg | 2015-06-15 |
| Model Number | M0068407170 |
| Catalog Number | 840-717 |
| 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. Other | 2015-06-18 |