MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE SHORT SHEATH; INTRODUCER, CATHETER

Model Number	10884450015404
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a g-clot fistula procedure, the wire broke off inside the patient.A snare was required to remove the detached tip.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Corrective actions are in process.

• Brand Name: PRELUDE SHORT SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10398860
• Report Number: 1721504-2020-00061
• Device Sequence Number: 3168188
• Product Code: DYB
• UDI-Device Identifier: 10884450015404
• UDI-Public: 10884450015404
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 03/31/2021
• Device Model Number: 10884450015404
• Device Catalogue Number: PSS-7F-4-018MT
• Device Lot Number: H1308795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: Required Intervention