MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS. BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	410035SIM1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a peripheral vascular intervention, the catheter tip detached within the patient's lower periphery.The physician had acquired vascular access and during catheter manipulations within the ivc the catheter detached.The physician was able to successfully externalized the foreign body from the patient thus liberating the vessel.No additional patient consequences to report.
Additional Manufacturer Narrative
The account alleges that during a dvt procedure, while acquiring digital subtraction angiograms (dsa), the catheter tip detached.The physician had acquired venous access.During catheter manipulations within the patient's inferior vena cava (ivc) the catheter tip detached and started to migrate.The physician was able to successfully externalized the foreign body from the patient thus liberating the vessel.No additional patient consequences to report.

• Brand Name: IMPRESS. BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14501644
• Report Number: 3010665433-2022-00050
• Device Sequence Number: 5124216
• Product Code: DQO
• UDI-Device Identifier: 00884450018897
• UDI-Public: 884450018897
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 01/06/2023
• Device Catalogue Number: 410035SIM1
• Device Lot Number: E1752796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown