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 2019-01-16 for NAVIGATOR HD M0062502220 250-222 manufactured by Boston Scientific Corporation.
[133252582]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[133252583]
It was reported to boston scientific corporation that a navigator access sheath was used in the kidney, ureter and bladder for retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2018. According to the complainant, during the procedure, it was noted that the cook ptfe wire and the sensor wire cannot go through the navigator access sheath as there might be something blocking the navigator access sheath. Attempts were made several times and the wire was finally able to go through. Reportedly, the upper ureter got torn because the sheath slipped out. A contour stent was placed to allow the ureter to heal on its own. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[135367056]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). A visual examination of the returned complaint device revealed that the device does not have visual defects. Functional evaluation was performed and the wire could be advanced without any issues or resistance, also the dilator was totally withdrawn from the sheath and loaded back into it with no issues. This failure is likely due to the adverse event is known and documented in the labeling including both short or long term known complications or adverse reactions. Therefore, the most probable root cause is known inherent risk of device. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Patient Sequence No: 1, Text Type: N, H10
[135367057]
It was reported to boston scientific corporation that a navigator access sheath was used in the kidney, ureter and bladder for retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2018. According to the complainant, during the procedure, it was noted that the cook ptfe wire and the sensor wire cannot go through the navigator access sheath as there might be something blocking the navigator access sheath. Attempts were made several times and the wire was finally able to go through. Reportedly, the upper ureter got torn because the sheath slipped out. A contour stent was placed to allow the ureter to heal on its own. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62593 |
| MDR Report Key | 8253923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-16 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-11-09 |
| Date Added to Maude | 2019-01-16 |
| 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 | 2019-01-16 |
| Returned To Mfg | 2019-01-10 |
| Model Number | M0062502220 |
| Catalog Number | 250-222 |
| Lot Number | 0022916741 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-16 |