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

Catalog Number 59038UAC

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for investigation.A follow-up report will be submitted once the investigation is complete.

Event Description

The account alleges that during a peripheral vascular intervention, a catheter tip detached within the patient.The physician had acquired retrograde femoral artery access and had negotiated the patient's ilio-femoral bifurcation with a guidewire and the 5f catheter.During catheter manipulations, the catheter tip detached in the patient's common iliac artery.The physician used a vascular snare device to capture and externalized the foreign body.During the primary capture attempt of the foreign body, it fragmented again into two additional pieces.A secondary attempt to capture and remove the foreign body was attempted, and the foreign body again fractured into two additional pieces within the patient's peripheral vasculature system.A third attempt was made resulting in the same outcome for the patient.The patient was admitted and transferred to the surgical unit for foreign body removal.

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 CAHTETER
• Type of Device: CATHETER, 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; south jordan, UT 84095
• MDR Report Key: 15894708
• MDR Text Key: 304613621
• Report Number: 3010665433-2022-00130
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Catalogue Number: 59038UAC
• Device Lot Number: E1841820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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: INTERVENTIONAL GUIDWIRE
• Patient Outcome(s): Required Intervention; Other; Hospitalization