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 2018-09-04 for NAVIGATOR HD M0062502230 70388 manufactured by Boston Scientific Corporation.
[119339570]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (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
[119339571]
It was reported to boston scientific corporation that a navigator hd access sheath was used in the ureter during a pyeloscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, the physician noticed a strip of the inner lumen that peeled off and was floating inside the ureter. The detached piece was retrieved using a basket and the procedure was completed at this time. 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 | 3005099803-2018-60249 |
| MDR Report Key | 7841886 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2017-06-07 |
| Date Added to Maude | 2018-09-04 |
| 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 | 2018-09-04 |
| Model Number | M0062502230 |
| Catalog Number | 70388 |
| Lot Number | 0020734656 |
| Device Expiration Date | 2019-06-06 |
| 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 | 2018-09-04 |