MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING .IMPRESS®.BRAIDED.CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 512538BER

Device Problems Fracture (1260); Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.

Event Description

The account alleges that during a tips procedure via radial access through the celiac artery, the catheter tip detached within the patient.The physician had acquired retrograde arterial radial access and during catheter manipulations, the tip fragmented within the patient.The physician attempted to snare the fragments from the patient with a vascular snare device, but the targeted foreign body fragmented again after capture within the patient's vasculature system.

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.

• Brand Name: .IMPRESS®.BRAIDED.CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18793947
• MDR Text Key: 336396179
• Report Number: 3010665433-2024-00008
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450009215
• UDI-Public: 884450009215
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/19/2024

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: 512538BER
• Device Lot Number: E2321811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• 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
• Treatment: INTERVENTIONAL GUIDEWIRE
• Patient Outcome(s): Other; Hospitalization; Required Intervention