MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-10-19 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[124513489]
Date of event was approximated to (b)(6) 2018 as no event date was reported. (b)(4). Investigation results: a stone cone retrieval coil was received for analysis. A visual analysis of the returned device found that the blue/green shrink is damaged, most likely from handling near the distal end preventing the device from closing completely. A functional evaluation found the device will open freely but will not close completely. The complaint that the device could not open was not confirmed. Investigation analysis revealed that the device could not close, and had coil coating- peeled/shared/frayed. Since the damage occurred during preparation, the root cause for this event is handling damage. The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return. 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. A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Patient Sequence No: 1, Text Type: N, H10
[124513490]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in a transuretheral lithotripsy procedure performed in the ureter, on an unknown date. According to the complainant, during introduction a functional check test was performed. The stone cone was able to be straightened after it coiled. When trying to insert and deploy the device, there was reported to be considerable resistance and deployment could not be performed. The procedure was completed with another stone cone. The were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be no patient injury. This event has been deemed a reportable event based on the investigation findings of: coil/cone coating peeled/shared/frayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02615 |
| MDR Report Key | 7986674 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-10-19 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2018-10-19 |
| 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 | 2018-10-19 |
| Returned To Mfg | 2018-07-26 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 0003903210 |
| 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 | 2018-10-19 |