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

Catalog Number 510038CB1

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

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Foreign Body Embolism (4439)

Event Date 05/05/2022

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 diagnostic endovascular procedure, the catheter had detached twice within the patient.The physician had acquired vascular access and during catheter manipulations over a guidewire, under fluoroscopy, the catheter detached.The physician was able to successfully externalize only one foreign body from the patient with a vascular snare device.The other foreign body that detached became stuck within the patient's leg.No additional patient consequences to report.

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: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14570743
• MDR Text Key: 293351006
• Report Number: 3010665433-2022-00055
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450038161
• UDI-Public: 884450038161
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 05/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 510038CB1
• Device Lot Number: E1944693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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: GUIDWIRE.
• Patient Outcome(s): Other; Required Intervention