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 2020-03-19 for CENTROSFLO HEMODIALYSIS CATHETER CENFT23K manufactured by Merit Medical Systems Inc.
[186545952]
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
[186545953]
The account alleges that during placement of a long-term hemodialysis catheter, the access wire tip perforated the patient's pericardium causing cardiac tamponade. The patient urgently received rhythmic compression of the chest. [cpr] and a pericardiocentesis was conducted. The patient's circulation stabilized, and an echocardiography was conducted. Prolongation of hospitalization was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00018 |
| MDR Report Key | 9857529 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-20 |
| 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 | CENTROSFLO HEMODIALYSIS CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | MSD |
| Date Received | 2020-03-19 |
| Catalog Number | CENFT23K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2020-03-19 |