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

Model Number 00884450026571

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a peripheral vascular intervention procedure, the catheter tip detached within the patient.The physician had successfully acquired left retrograde femoral artery access with the 4f 90cm catheter and was attempting to negotiate the patient's descending aorta under fluoroscopy when the catheter tip detached.The physician successfully removed the foreign body from the patient's descending aorta with a vascular snare device.The patient tolerated the procedure well.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later time, the investigation will be re-opened.

• Brand Name: IMPRESS NON-BRAIDED PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10221203
• MDR Text Key: 197286172
• Report Number: 3010665433-2020-00020
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450026571
• UDI-Public: 00884450026571
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 00884450026571
• Device Catalogue Number: 58035MHK1
• Device Lot Number: 58035MHK1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE
• Patient Outcome(s): Required Intervention