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 2018-08-07 for NAVIGATOR HD 70388 manufactured by Boston Scientific Corporation.
[116226396]
The complainant was unable to provide the lot number. Therefore, the manufacture and expiration dates are unknown. (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
[116226397]
This manufacturer report pertains to a navigator hd access sheath device used along with a lithovue standard deflection scope during a procedure. It was reported to boston scientific corporation that a navigator hd access sheath and a lithovue standard deflection scope was used in the kidney during a nephroscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, a foreign object that was diaphanous close to white in color was lodged in the patient and was seen by the physician inside the working channel of the scope. Reportedly, the object does not look like a part of any device however after investigation, it was found that the foreign matter reported was likely to be a component from the inner lumen of the navigator hd access sheath, used by the customer without lubricant. The foreign object was retrieved upon withdrawal of the lithovue scope. A different device was used to complete the procedure. There were no patient complications reported as a result of this event. Additionally, the patient had previous surgical procedures. Last (b)(6) 2018, the patient had nephrostomy with stent insertion due to 10 mm stone. On (b)(6) 2018, the patient had a left sided rigid ureteroscopy with disintegration and extraction of stone fragments and the recent procedure on (b)(6) 2018 for a ureteroscopy to extract 4 mm stone fragment from lower renal calyx.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60011 |
| MDR Report Key | 7756602 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-07 |
| 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 | 100 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 | 2018-08-07 |
| Model Number | 70388 |
| Catalog Number | 70388 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-07 |