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 2018-09-25 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903100 390-310 manufactured by Boston Scientific - Marlborough.
[121714085]
(b)(4). Investigation results: a stone cone retrieval coil was returned for analysis. A visual evaluation found a part of the coil was detached and a burn mark at the break. The device opens and closes. Additionally, the handle was found broken into two pieces. The reported event that the device could not close could not be confirmed; however there is a burn mark at the break. The stone cone directions for use warns: do not directly fire upon the device with a laser. Therefore, the assigned complaint investigation conclusion code for this event is user / use error. Confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Patient Sequence No: 1, Text Type: N, H10
[121714086]
It was reported to boston scientific corporation that a stone cone was used in a rigid ureteroscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, the stone cone failed to straighten after it coiled. The procedure was completed with a different device. There were no patient complications reported as a result of this event. The patients' condition at the conclusion of the procedure was reported to be stable. This has been deemed an mdr reportable event based on investigation findings coil/coating peeled/shared/frayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02608 |
| MDR Report Key | 7906508 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-09-14 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2018-09-25 |
| 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 | STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2018-09-25 |
| Returned To Mfg | 2018-07-24 |
| Model Number | M0063903100 |
| Catalog Number | 390-310 |
| Lot Number | 0004123922 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |