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 2020-03-12 for IMPRESS BRAIDED PERIPHERAL CATHETER 00884450038109 46535RIM manufactured by Merit Medical Systems, Inc..
[185591534]
The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[185591536]
The account alleges that during a vascular procedure, the catheter tip detached within a patient. The physician had acquired arterial vascular access and during catheter manipulations the tip detached within the patient's common femoral artery. The physician used a vascular snare to successfully retrieve the catheter tip from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010665433-2020-00005 |
| MDR Report Key | 9826400 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-11-14 |
| Date Added to Maude | 2020-03-12 |
| 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 BRAIDED PERIPHERAL CATHETER |
| Generic Name | PERIPHERAL CATHETER |
| Product Code | DQO |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-05 |
| Model Number | 00884450038109 |
| Catalog Number | 46535RIM |
| Lot Number | E1707693 |
| 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 | 14646 KIRBY DRIVE HOUSTON, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |