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

Catalog Number	56538SIM1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
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 procedure and within the aortic arch, the catheter was rotated to reshape the sim with relative ease due to patient anatomy.Once turned it was noted that the entire tip of the catheter had detached.Catheter and wire pulled into inferior renal aorta.Second sheath paced into the right femoral artery where an a snare device was used to attempt to remove the detached tip.Tip dislodged and traveled to the left iliac artery where it was snared.Once the tip was snared it snapped and around 8cm of the device migrated to the profunda artery.A portion of the catheter was removed while the remaining tip left in place.Referral to vascular surgeon.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined.Due to the jagged / brittle nature of the remaining tip material, a possible cause is that the device was exposed to external chemicals used during decontamination / sterilization of clinical environments or extreme environmental conditions during storage outside of merit's possession.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: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 18000173
• Report Number: 3010665433-2023-00090
• Device Sequence Number: 18026903
• Product Code: DQO
• UDI-Device Identifier: 00884450009451
• UDI-Public: 00884450009451
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/16/2023

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: 09/07/2024
• Device Catalogue Number: 56538SIM1
• Device Lot Number: E2226087
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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