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 2020-03-18 for ASCERTA M0061456140 145-614 manufactured by Boston Scientific Corporation.
[188525887]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. Initial reporter facility name: (b)(6) med ctr. (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188525888]
It was reported to boston scientific corporation that an ascerta ureteral stent was used during a ureteroscopy with laser lithotripsy and stent placement procedure in the kidney, ureter and bladder, performed on (b)(6) 2020. According to the complainant, during the procedure, inside the patient, when the physician attempted to remove the suture, the suture was broken and it ripped the stent forming a small tear in the coil. Reportedly, a visible hole in the bottom part of the coil was noticed. The procedure was successfully completed with another ascerta ureteral stent. 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 fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01098 |
| MDR Report Key | 9848931 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-03-18 |
| 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 | ASCERTA |
| Generic Name | STENT, URETERAL |
| Product Code | FAD |
| Date Received | 2020-03-18 |
| Model Number | M0061456140 |
| Catalog Number | 145-614 |
| Lot Number | 0024728470 |
| 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 | 2020-03-18 |