MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO SPLITTABLE SHEATH INTRODUCER.; INTRODUCER SHEATH

Catalog Number	PLS-1007/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
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 venous puncture while attempting to access the vessel using a needle and guidewire in the package, the doctor noticed the end of the wire had curled up and got stuck at the end of the needle.Part of this wire had broken off and was stuck inside the patients surrounding tissue.The doctor was not able to retrieve the foreign body from the patient, so it was left in the patient.Procedure was successful and the patient is stable.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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: SPLITTABLE SHEATH INTRODUCER.
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 13015109
• Report Number: 3011642792-2021-00027
• Device Sequence Number: 12059261
• Product Code: DYB
• UDI-Device Identifier: 00884450467985
• UDI-Public: 884450467985
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2024
• Device Catalogue Number: PLS-1007/A
• Device Lot Number: I1945198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCESS SHEATH - SPLITTABLE
• Patient Sex: Unknown