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

Catalog Number	PSS-6F-4MT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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 during a procedure the radiopaque marker band of the sheath detached within the patient.Vascular access was achieved via seldinger technique, and an 035 guidewire was used to exchange for a 6f sheath.A 6x4 pta balloon was advanced and positioned within the vasculature but was not inflated.The foreign body was observed under fluoroscopy migrating away from the sheath.Arterial and venous pressure was quickly held to prevent migration of the foreign body into the pulmonary artery or arterial system.The physician was successful in performing a cutdown and successfully removing the foreign body from the patient.The procedure was completed with no addition consequences to the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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 SHORT SHEATH
• Common Device Name: SHORT SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11972051
• Report Number: 1721504-2021-00038
• Device Sequence Number: 11898007
• Product Code: DYB
• UDI-Device Identifier: 00884450015315
• UDI-Public: 884450015315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 07/31/2023
• Device Catalogue Number: PSS-6F-4MT
• Device Lot Number: H2032962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: .035 GUIDWIRE; MEDTRONIC SHEATH; PTA BALLOON 6X4
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention