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

Catalog Number 56535RIM

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during vascular procedure, the tip of the 5f catheter detached.The physician was removing the catheter over a guide wire through a standard sheath.The tip was successfully retrieved form the patient with no additional injury to report.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• MDR Report Key: 11051622
• MDR Text Key: 223179647
• Report Number: 3010665433-2020-00062
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450038185
• UDI-Public: 884450038185
• 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
• Report Date: 12/17/2020

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: 01/20/2023
• Device Catalogue Number: 56535RIM
• Device Lot Number: E1766577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE
• Patient Outcome(s): Required Intervention