MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO IMPRESS®.BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	56538MW2/JPB
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
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 angiography the catheter tip detached.The product was attempted to be used for internal iliac artery in relation to a type ii endoleak.The catheter was inserted from right femoral artery and delivered through aortic bifurcation to left side.When angiography was performed with the unit at the vicinity of left internal iliac artery, it was suspected that the tip of the catheter had got cracked.Thus, the unit was pulled back into a sheath.However, the tip got completely sheared off at that time.As the tip was floating within left superficial femoral artery (sfa), the retrieval of the tip was attempted with a snare.However, the tip went deep into the peripheral region of the sfa.Thus, the vessel was cut down under general anesthesia, and the tip was successfully retrieved with a fogarty catheter.The physician stated that the anatomy had no stenosis or significant tortuosity, and that the cracking and the detachment occurred despite the usual manipulation of the catheter.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The evlauation could not be completed due to the loss of the device by the investigation team.The absence of the device impeded our ability to perform a necessary physical examination and root cause analysis, which are critical to identifying any defects or issues.Without the device, verifying data such as lot numbers and usage records was impossible, compromising the integrity of the investigation.Continuing the investigation without the device would lead to speculative and potentially misleading conclusions, making it an inefficient use of resources.Therefore, we determined that proceeding without the device would not yield accurate or actionable results.Should the device be found at a later date, then this case may be reopened for a full investigation.The associated failure mode has been identified in the current risk documentation and the current risk estimation is accurate.Nonconformances of this nature are monitored by the engineering, quality and management team members.This complaint will be used to trend for similar complaints.Corrective actions are taken as warranted based on trend analysis per procedure.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 18890884
• Report Number: 3011642792-2024-00016
• Device Sequence Number: 18043770
• Product Code: DQO
• UDI-Device Identifier: 00884450654507
• UDI-Public: 00884450654507
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053171
• 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): 03/06/2024

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: 01/22/2026
• Device Catalogue Number: 56538MW2/JPB
• Device Lot Number: I2593042
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2023
• 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