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 2020-02-06 for MERIT CUSTOM KIT 00884450387320 K09-00378AA manufactured by Merit Medical Systems Inc..
[186547387]
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
[186547388]
The account alleges that during a percutaneous transluminal coronary intervention [pci] procedure, the physician had acquired retrograde arterial access and had negotiated the patient's aorta with a guidewire and guide catheter to successfully cannulate and opacify the coronary vascular system. The account states that following a balloon angioplasty, air was identified within the injection manifold. The manifold syringe was pulled back and a crack was identified at the control syringe connection port. A new manifold was prepped per industry protocol, and the procedure continued. Air was not identified -under fluoroscopic imaging- entering the patient during this procedure. The physician then noted two new filling defects within the patient's artery. The patient became progressively hypotensive and a code blue was initiated. Return of spontaneous circulation (rosc) was successfully achieved and the procedure continued. Seventeen minutes later, the patient coded again. The team was not able to recover the patient. The patient expired on the procedure room table. The account alleges that the cause of death was an anterior wall myocardial infarction, secondary to thrombosis of a high-grade left anterior descending [lad] coronary artery atherosclerotic plaque.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00006 |
| MDR Report Key | 9679257 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-30 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT CUSTOM KIT |
| Generic Name | CUSTOM KIT |
| Product Code | OEZ |
| Date Received | 2020-02-06 |
| Model Number | 00884450387320 |
| Catalog Number | K09-00378AA |
| 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 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |