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

Catalog Number 56538MW2/JPB

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.

Event 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.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: 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
• MDR Text Key: 337510219
• Report Number: 3011642792-2024-00016
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450654507
• UDI-Public: 00884450654507
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 56538MW2/JPB
• Device Lot Number: I2593042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention