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 2020-02-26 for STONE CONE M0063903200 390-320 manufactured by Boston Scientific Corporation.
[188655864]
(b)(6). (b)(4). The device is not expected to be returned for analysis. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188655865]
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2020. According to the complainant, after the procedure, the stone cone device was removed from the patient, and it was found that about 10cm of the device tip had detached. X-ray confirmed that the device tip was left in the patient. A second surgery was performed to retrieve the 10cm tip, and it was reported that the scope was used to remove the detached part. There were no additional patient complications as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00510 |
| MDR Report Key | 9758618 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-05-23 |
| Date Added to Maude | 2020-02-26 |
| 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 | 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 |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2020-02-26 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 0004873024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-02-26 |