MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-20 for STONE CONE M0063903100 390-310 manufactured by Boston Scientific Corporation.
[145614320]
The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown. However, the complainant reported that the device was not expired. (b)(6). (b)(4). A stone cone device was returned for analysis. A visual analysis revealed that it was received in a closed state. There were kinks on the distal end of the device, past the distal stop. The blue/green coating was pulling away from the distal stop on the distal side. There was residue between the blue sheath and the white heat shrink. A functional test was conducted and found the blue sheath could not be retracted or advanced. No other issues were noted. Based on the condition of the device, it is likely that operational factors contributed to the failures found during product analysis. It is likely that the blue/green coating was pulled away from the distal stop when the device experienced excessive force that bent the distal tip, kinked the working length, and resulted in blue/green coating pulling away from the distal stop. The direction for use (dfu) states "if resistance is encountered while attempting to withdraw the coil do not exert excessive force. " therefore, the complaint investigation conclusion code for this complaint is failure to follow instructions, which indicates that the problems traced to the user not following the manufacturer's instructions. A manufacturing batch record review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event. Labeling review was performed and found no evidence that the device was used in a manner inconsistent with the labeling.
Patient Sequence No: 1, Text Type: N, H10
[145614321]
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in a procedure to be performed in the ureteral canal on (b)(6) 2019. The basket was to be used after stone crushing was performed. According to the complainant, during preparation, the coil was found crushed and the shape was found to be straight when removed from the packaging. The procedure was completed with another stone cone nitinol retrieval coil. There were no patient complications reported as a result of this event. Note:this event has been deemed a reportable event based on the investigation results; coil/cone peeled/sheared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02598 |
| MDR Report Key | 8626187 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-20 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 1525 HERTZ STREET |
| Manufacturer City | CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-03-11 |
| Model Number | M0063903100 |
| Catalog Number | 390-310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |