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 2020-02-20 for IMPRESS DIAGNOSTIC CATHETER 00884450109373 59038UAC manufactured by Merit Medical Systems, Inc..
[181486717]
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[181486718]
The account alleged that during a uterine artery embolization (uae) procedure, the catheter fractured within the patient's left internal iliac artery. The embolization procedure was aborted and catheter tip recovery was attempted with a vascular snare device via femoral artery access. The catheter tip fragmented again during this process and the endovascular removal was unsuccessful. The patient was referred for surgical removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010665433-2020-00004 |
| MDR Report Key | 9735316 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2017-02-20 |
| Date Added to Maude | 2020-02-20 |
| 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 | 14646 KIRBY DRIVE |
| Manufacturer City | HOUSTON, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPRESS DIAGNOSTIC CATHETER |
| Generic Name | INTRAVASCULAR DIAGNOSTIC CATHETER |
| Product Code | DQO |
| Date Received | 2020-02-20 |
| Model Number | 00884450109373 |
| Catalog Number | 59038UAC |
| Lot Number | E1093818 |
| Device Expiration Date | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 14646 KIRBY DRIVE HOUSTON, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-20 |