MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE PRO SHEATH INTRODUCER; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	PRO-5F-11MT/C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that on (b)(6) 2020 the radiopaque tip from the pro-5f-11mt/c sheath detached within the patient sfa/anterior tibial [at] artery and occluded a venous bypass graft within the patient's distal periphery.The vessel was not diseased, and an angioplasty was performed through this sheath during this procedure.Post-procedure the patient was discharged to home.On (b)(6) 2020 during a follow-up appointment with the patient.An ultrasound demonstrated that approx.7mm radiopaque marker band was occluding the distal vein graft along with a collection of thrombi.On (b)(6) 2020 the patient underwent a thrombolysis procedure to break down and remove the thrombus/clots.The graft was cleared of thrombus/clots, but fresh clots were identified.The foreign body remained in-situ.On (b)(6) 2020 the patient was referred to vascular surgeon, where the foreign body was successfully removed via surgical procedure.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint was confirmed, and the root cause attributed to the manufacturing process.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: PRELUDE PRO SHEATH INTRODUCER
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11013564
• Report Number: 1721504-2020-00107
• Device Sequence Number: 19049864
• Product Code: DRE
• UDI-Device Identifier: 00884450331101
• UDI-Public: 884450331101
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K073035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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 Catalogue Number: PRO-5F-11MT/C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention