MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO CORONARY SINUS GUIDE SPLITTABLE INTRODUCER SHEATH.; INTRODUCER, CATHETER

Catalog Number	WOR-CSG-B1-09/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during an upgrade to a biv-icd procedure when splitting the peel-away sheath, the radiopaque marker band detached and migrated to the patient's lung.The physician states that no unusual anatomy was noted during the procedure for this patient, and no hemodynamic changes due to the foreign body introduction were noted.The patient is doing well, there are no plans to remove the foreign body from this patient.Admission to the hospital or prolongation of hospitalization was not necessary.No additional interventions or medication were necessary.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause attributed to failure of the component.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: CORONARY SINUS GUIDE SPLITTABLE INTRODUCER SHEATH.
• Common Device Name: INTRODUCER, CATHETER
• 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 bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17438374
• Report Number: 3011642792-2023-00052
• Device Sequence Number: 15681953
• Product Code: DYB
• UDI-Device Identifier: 00884450484319
• UDI-Public: 884450484319
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120158
• 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): 07/25/2023

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: 01/02/2026
• Device Catalogue Number: WOR-CSG-B1-09/A
• Device Lot Number: I2584372
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BRAIDED CORE INTRODUCER.; INTERVENTIONAL GUIDEWIRE.
• Patient Sex: Unknown