MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PRELUDE® SHORT SHEATH.7F.4 CM (1.6")...MARKER TIP..........; INTRODUCER, CATHETER

Catalog Number	PSS-7F-4MT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during a fistulagram/angio when the md removed the short sheath out at completion, the black tip was broken off inside of the patient.The md had to then attempt to retrieve the tip and was successful.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and one exception document was identified.A search of the complaint database was performed and no similar complaints for this lot number have been identified.

• Brand Name: PRELUDE® SHORT SHEATH.7F.4 CM (1.6")...MARKER TIP..........
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18314755
• Report Number: 1721504-2023-00092
• Device Sequence Number: 6783999
• Product Code: DYB
• UDI-Device Identifier: 00884450015322
• UDI-Public: 884450015322
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: PSS-7F-4MT
• Device Lot Number: H2794630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown