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

Catalog Number 59038UAC

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device will not be returning for 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 uterine fibroid embolization procedure, the tip of the diagnostic 5f catheter detached within the patient.The physician had acquired retrograde femoral arterial access, and during catheter manipulations, over a guidewire, the catheter tip detached within the patient.The physician attempted to retrieve the foreign body with a vascular snare device but was unsuccessful.

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
• Type of Device: INTRAVASCULAR, DIAGNOSTIC
• 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: 13802962
• MDR Text Key: 291234057
• Report Number: 3010665433-2022-00024
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 59038UAC
• Device Lot Number: E1570331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 72 KG