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 2020-03-18 for IMAGER II ANGIOGRAPHIC CATHETER 38270 manufactured by Boston Scientific Corporation.
[183920405]
It was reported that the tip detached. An imager ii angiographic catheter was placed in a patient back in january to gain access for a lithotripsy procedure. The catheter had been placed in the kidney where it was attempted to be moved down to the bladder for the lithotripsy. However, the lithotripsy was not completed. Seven weeks later, a procedure was attempted to remove the catheter. Before the procedure started, the tip was observed to be detached. Snaring was completed to remove the detached tip. As the detached component was grabbed with the snare, it would break off into smaller pieces. All device fragments were retrieved. No further patient complications were reported. The patient was fine and stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03403 |
| MDR Report Key | 9847969 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMAGER II ANGIOGRAPHIC CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQO |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 38270 |
| Catalog Number | 38270 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |