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 2020-03-06 for PRELUDE SHEATH INTRODUCER PSI-6F-23MT/C manufactured by Merit Medical Systems Inc..
[186544921]
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
[186544922]
The account alleges that during a percutaneous transluminal coronary intervention [pci] procedure, a foreign object was identified with in the patient. The physician had acquired retrograde femoral artery access and had negotiated the patient's aortic arch to cannulate and opacify the patient's right coronary artery [rca]. During the coronary angiography a slightly tapered foreign body in the area of the proximal rca was identified. The physician alleges that it may be the marker band of the sheath that detached and was carried into the rca by the guide catheter. No patient consequences to report. The patient remained hemodynamically stable. A balloon catheter was then introduced along the guidewire and inflated to retrieve the foreign object from the heart. When trying to remove the foreign object through the femoral access sheath, the foreign body detached form the balloon and migrated in an antegrade direction into the lateral branch of the profunda artery. The physician did not attempt to retrieve the foreign body from the patient's periphery. The patient remains asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00009 |
| MDR Report Key | 9799441 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-05-21 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| 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 | PRELUDE SHEATH INTRODUCER |
| Generic Name | SHEATH INTRODUCER |
| Product Code | DRE |
| Date Received | 2020-03-06 |
| Catalog Number | PSI-6F-23MT/C |
| Lot Number | H1584245 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-03-06 |