MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. - PEARLAND IMPRESS® BRAIDED CATHETER; PERIPHERAL CATHETERS

Model Number	00884450032565
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is attributed to the device being exposed to conditions outside of those identified on product and instructions for use labeling that would include exposure to chemicals used during decontamination / sterilization of clinical environments or extreme environmental conditions during storage.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.
Event or Problem Description
The account alleges that during a vascular examination on a patient, the operator placed the catheter at the level of the aorta with a curved 0.035 x 150cm guide and immediately after that the end of the catheter migrated during the removal of the guide.The end got stuck in the abdominal aorta and when trying to retrieve the tip with a lasso the end of the catheter was cut into several pieces.A retrieval basket was used to retrieve the device from the patient.

• Brand Name: IMPRESS® BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. - PEARLAND; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC. - PEARLAND; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16415039
• Report Number: 3010665433-2023-00013
• Device Sequence Number: 19655682
• Product Code: DQO
• UDI-Device Identifier: 00884450032565
• UDI-Public: 00884450032565
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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 Model Number: 00884450032565
• Device Catalogue Number: 54038KA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown