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 2017-07-17 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[80257417]
(b)(4). A visual analysis revealed that the device was returned closed. The blue sheath overran the distal stop, affecting the devices' ability to open. The blue/green shrink on the distal end of the cone was missing and was not returned. Also, the white heat shrink was found accordioned at the proximal end. Since the complaint is associated with a product which met specifications but most likely encountered anatomical or procedural factors which limited its performance, the most probable root cause for this event is operational context. The device history record (dhr) review found the device met all manufacturing specifications. A search of the complaint database revealed that no similar complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[80257418]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a transurethral ureterolithotripsy (tul) procedure performed on an unknown date. According to the complainant, during the procedure, the coil of the stone cone failed to open. The procedure was completed by another of the same device. There 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 "good. " this event has been deemed a reportable event based on the investigation results; coil coating peeled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02020 |
| MDR Report Key | 6719837 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-07-17 |
| Date of Report | 2017-06-20 |
| Date Mfgr Received | 2017-06-20 |
| Device Manufacturer Date | 2016-09-06 |
| Date Added to Maude | 2017-07-17 |
| 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 | ACCELLENT ENDOSCOPY JUAREZ |
| Manufacturer Street | 31C BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| 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 | 2017-07-17 |
| Returned To Mfg | 2017-05-17 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | F69386 |
| Device Expiration Date | 2019-07-25 |
| 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 | 2017-07-17 |