MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for TRIA SOFT M0061903230 1983-02 manufactured by Boston Scientific Corporation.
[188527001]
Clinical study: (b)(6). (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188527002]
It was reported to boston scientific corporation that a tria ureteral stent was implanted in the left distal ureter of a patient during a stent placement procedure performed on (b)(6) 2020 as part of the u0652 (b)(6) clinical study. Reportedly, the patient was undergoing stent placement for stone management on left distal ureter. According to the complainant, on (b)(6) 2020, post procedure, the patient noticed that the implanted tria ureteral stent 'fell out' while moving around in the bed in the post anesthesia care unit. The patient could feel the stent was out. The nurse successfully pulled and removed the stent while patient was recovering post operation. No new stent has been replaced. There were no patient complications or adverse events reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01120 |
| MDR Report Key | 9862732 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-03-20 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIA SOFT |
| Generic Name | STENT, URETERAL |
| Product Code | FAD |
| Date Received | 2020-03-20 |
| Model Number | M0061903230 |
| Catalog Number | 1983-02 |
| Lot Number | 0024550783 |
| 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 | 2020-03-20 |