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 2020-03-19 for CLARIVEIN OC INFUSION CATHETER 65-018-E4S O-65-018-E4S manufactured by Merit Medical Systems Inc..
[186541053]
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186541054]
The account alleges that during a mechanochemical ablation (moca) procedure, the distal rotating catheter became stuck with a valve of a targeted vasculature. The physician had acquired antegrade venous access through a vascular sheath and was attempting to deliver sclerosant through the rotating catheter when the catheter became entangled within a valve of the periphery. All attempts by the physician to dislodge the rotating catheter were unsuccessful. A surgical "cutdown" procedure was necessary to safely and successfully dislodge the rotating catheter form the patient's periphery with no additional consequences to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00015 |
| MDR Report Key | 9857526 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2018-12-18 |
| Date Added to Maude | 2020-03-19 |
| 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 | CLARIVEIN OC INFUSION CATHETER |
| Generic Name | INFUSION CATHETER |
| Product Code | KRA |
| Date Received | 2020-03-19 |
| Model Number | 65-018-E4S |
| Catalog Number | O-65-018-E4S |
| Lot Number | BM651404118O |
| 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 | 1600 MERIT PARKWAY SOUTH JORDAN, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |