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 2020-01-31 for EDGE CATHETER SYSTEM UNKNOWN EXTENDED WORKING CHANNEL UNKNOWN EXTENDED WORKING CHANN manufactured by Covidien Lp - Superdimension Inc.
[183374134]
The customer disposed of the product and it was not returned. Therefore, the complaint could not be confirmed, and no root cause could be determined. However, the reported behavior is consistent with a known issue in which an internal corrective action was initiated. The model and lot number of is unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183374135]
According to the reporter during a procedure, a "floss-like" material came out of the delivery catheter post-fiducial deployment. The physician was able to complete the superdimension portion of the case. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2020-00009 |
| MDR Report Key | 9654153 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-01-31 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDGE CATHETER SYSTEM |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-01-31 |
| Model Number | UNKNOWN EXTENDED WORKING CHANNEL |
| Catalog Number | UNKNOWN EXTENDED WORKING CHANN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |