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 2018-09-25 for NAVIGATOR HD M0062502250 70388 manufactured by Boston Scientific Corporation.
[121619813]
The complainant was unable to provide the lot number. Therefore, the manufacture and expiration dates are unknown. 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
[121619814]
It was reported to boston scientific corporation that a navigator hd ureteral access sheath was used in the ureter during an ureteroscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, a perforation occurred while the physician was advancing the access sheath over the sensor wire. A percutaneous tube was placed to drain the kidney. The procedure was not completed due to this event. In the physicians assessment, the physician felt that the navigator was too stiff. The patient's condition at the conclusion of the procedure was reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60548 |
| MDR Report Key | 7906575 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-09-25 |
| 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 | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIGATOR HD |
| Generic Name | ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FED |
| Date Received | 2018-09-25 |
| Model Number | M0062502250 |
| Catalog Number | 70388 |
| 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 | 2018-09-25 |