MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE SHEATH INTRODUCER

Catalog Number	PSI-6F-23MT/C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
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.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: PRELUDE SHEATH INTRODUCER
• Common Device Name: SHEATH INTRODUCER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• MDR Report Key: 9799441
• Report Number: 1721504-2020-00009
• Device Sequence Number: 572638
• Product Code: DRE
• UDI-Device Identifier: 00884450330593
• UDI-Public: 00884450330593
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2022
• Device Catalogue Number: PSI-6F-23MT/C
• Device Lot Number: H1584245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER; GUIDE WIRE 0.035./0.014
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention