MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. IMPRESS BRAIDED PERIPHERAL CATHETER

Model Number	00884450023181
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
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 an interventional peripheral vascular procedure, the catheter tip detached within the patient.The physician had successfully acquired left retrograde femoral artery access with the 4f 100cm catheter.During catheter manipulations under fluoroscopy, over a stiff guidewire at the patient's aortic bifurcation, the catheter tip detached.Secondary access from the patient's right femoral artery with a 6f sheath was acquired.The physician was able to successfully remove the foreign body from the patient's aortic bifurcation via the right femoral artery with a vascular snare device.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.Should the device be returned at a later time, the investigation will be re-opened.

• Brand Name: IMPRESS BRAIDED PERIPHERAL CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10221202
• Report Number: 3010665433-2020-00019
• Device Sequence Number: 16712587
• Product Code: DQO
• UDI-Device Identifier: 00884450023181
• UDI-Public: 00884450023181
• Combination Product (Y/N): N
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 00884450023181
• Device Catalogue Number: 410035VER
• Device Lot Number: E1538455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention