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

Model Number	00884450717950
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not 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 leg angiogram the tip of the catheter came off the and fell off in the patient's artery.This occurred when the physician inserted the catheter through the sheath with a glide wire on the right groin side, over the bifurcation and down into the left sfa.The physician then wanted to switch the wire out and when he pulled back the wire, the tip of the catheter became dislodged and was floating in the sfa.He was able to snare the broken piece out of the patient and on the black portion of the catheter they observed a kink.There was no harm to the patient.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number were identified.Corrective actions are underway.

• Brand Name: IMPRESS®
• 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: 16860440
• Report Number: 3011642792-2023-00032
• Device Sequence Number: 14938558
• Product Code: DQO
• UDI-Device Identifier: 00884450717950
• UDI-Public: 00884450717950
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/24/2023

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 Expiration Date: 01/22/2026
• Device Model Number: 00884450717950
• Device Catalogue Number: 46538KA2-H/B
• Device Lot Number: I2592403
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown