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

Catalog Number 46535RIM/B

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2023

Event Type  Injury  

Event Description

The account alleges that during an angiogram procedure the tip of the catheter detached within the patient.While attempting to cross through the common iliac artery, the tip of the device got stuck within the highly calcified vessel and detached within the patient.There was an attempt to remove the foreign body using a snare, and was unsuccessful.The patient was sent to surgery to remove the detached tip.No additional patient consequence to report.

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.

Manufacturer Narrative

The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17213892
• MDR Text Key: 317985701
• Report Number: 3011642792-2023-00046
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450668122
• UDI-Public: 884450668122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46535RIM/B
• Device Lot Number: I2523327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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
• Patient Outcome(s): Required Intervention