MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS CORVOCET¿; INSTRUMENT, BIOPSY

Catalog Number	CORCA1815B/B
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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 use the coaxial introducer could be used without any problems, but when the biopsy needle was advanced into the coaxial introducer for the second time, there was resistance.When the introducer and biopsy needle were removed from the patient because of the resistance, the introducer broke.The tip of the broken introducer was immediately retrieved because the broken position was outside of the patient's body.The physician mentioned that the introducer was pressed against the ribs with a strong load due to respiratory fluctuations.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause of the component broken could be attributed to use error.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: CORVOCET¿
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22136308
• Report Number: 3011642792-2025-00097
• Device Sequence Number: 8354272
• Product Code: KNW
• UDI-Device Identifier: 00884450476390
• UDI-Public: 00884450476390
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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
• Device Catalogue Number: CORCA1815B/B
• Device Lot Number: I3085696
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown