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 2019-03-07 for STONE CONE M0063903200 390-320 manufactured by Boston Scientific Corporation.
[138101109]
(b)(6). (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental a will be filed.
Patient Sequence No: 1, Text Type: N, H10
[138101110]
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the coil detached inside the patient and was successfully removed by using retrieval forceps. The sheath was also reported to be torn, and laser was reported to have been used during the procedure. The procedure was completed with another stone cone nitinol retrieval coil. There was no serious injury nor were there any adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01090 |
| MDR Report Key | 8399259 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-07 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2018-08-11 |
| Date Added to Maude | 2019-03-07 |
| 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 | 2019-03-07 |
| Returned To Mfg | 2019-02-27 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 4406191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-07 |