MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-14 for MERIT MAESTRO MICROCATHETER 00884450358153 29MC29150SN/D manufactured by Merit Medical Systems, Inc..
[179484023]
The suspect device has returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[179484024]
The account alleges that during a peripheral intravascular procedure, the radiopaque marker band detached within the patient. The physician had acquired arterial access, and while manipulating a micro catheter through a ruc catheter, the marker band detached from the catheter yet remained on the guide wire. The marker band was successfully captured and removed with the assistance of a small peripheral balloon. The patient tolerated the procedure well. No additional injuries or consequences to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00007 |
| MDR Report Key | 9712680 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-02-14 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT MAESTRO MICROCATHETER |
| Generic Name | MICROCATHETER |
| Product Code | KRA |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 00884450358153 |
| Catalog Number | 29MC29150SN/D |
| Lot Number | H1702727 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-14 |