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 2020-03-25 for RANGER 26102 manufactured by Boston Scientific Corporation.
[185035811]
The date of event is unknown. Bsc became aware of the event on (b)(6) 2020. A date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.
Patient Sequence No: 1, Text Type: N, H10
[185035812]
It was reported that a shaft break occurred. A 5. 0mm x 60mm, 80 cm ranger balloon was advanced to the target lesion. While dilating the balloon, the shaft broke. The procedure was completed. No patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03545 |
| MDR Report Key | 9879496 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | HEMOTEQ AG |
| Manufacturer Street | ADENAUERSTRASSE 15 |
| Manufacturer City | WUERSELEN 52146 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RANGER |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-25 |
| Model Number | 26102 |
| Catalog Number | 26102 |
| Lot Number | 3165H18 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |