MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO .IMPRESS®.NON-BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number 51103810PIG-NB/CNB

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

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

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.

Event Description

The account alleges that during a procedure, a catheter tip detached within the patient.A snare was used to remove the foreign body from the patient's common iliac artery.

Manufacturer Narrative

The suspect device is not expected to return 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 later, the investigation will be reopened.

• Brand Name: .IMPRESS®.NON-BRAIDED CATHETER
• Type of Device: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18441105
• MDR Text Key: 331864946
• Report Number: 3011642792-2024-00001
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450687321
• UDI-Public: 884450687321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 51103810PIG-NB/CNB
• Device Lot Number: I2675359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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: INTERVENTIONAL GUIDEWIRE.
• Patient Outcome(s): Required Intervention