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

Catalog Number 56538CB1-H

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  Injury  

Event Description

The account alleges that during a surgical abdominal aortic stent implant procedure [aaa] on a female patient, the proximal hydrophilic segment of the 5f catheter detached within the patient.The physician had acquired retrograde femoral artery access to deliver a coil-type embolic devices, during catheter manipulations over a guidewire under fluoroscopy, the catheter tip detached within the patient's common iliac artery.The physician used a vascular snare device to successfully externalize the fragmented foreign bodies, but the foreign body again was fragmented.A thrombectomy catheter was eventually used to remove all fragmented parts liberating the patient's vessel.No additional patient consequences 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 have been identified.Should the device be returned at a later date, the investigation will be reopened.

• Brand Name: .IMPRESS®.BRAIDED CATHETER
• 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: 16986522
• MDR Text Key: 315787825
• Report Number: 3010665433-2023-00043
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450043769
• UDI-Public: 884450043769
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K093004
• 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: 05/12/2023

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 Expiration Date: 03/08/2024
• Device Catalogue Number: 56538CB1-H
• Device Lot Number: E2078959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: HELIX COILS; INTERVENTIONAL GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female