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 2018-11-13 for NAVIGATOR HD M0062502280 250-228 manufactured by Boston Scientific Corporation.
[127053086]
(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
[127053087]
It was reported to boston scientific corporation that a navigator hd access sheath was used in the urinary bladder during a cystoscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, the surgeon noticed that the end of the access sheath feels rough. Reportedly, the access sheath possibly caused a laceration/tear in the patients ureter. The laceration was stitched and monitored after.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61348 |
| MDR Report Key | 8066186 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-13 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2018-11-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-11-13 |
| Returned To Mfg | 2018-11-15 |
| Model Number | M0062502280 |
| Catalog Number | 250-228 |
| Lot Number | 0022013990 |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-13 |