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

Catalog Number 46535BER/B

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

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

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that two catheter tips detached within the patient's common iliac arteries during catheter exchanges.The procedure was an infrarenal aortic aneurysm repair with noted tortuous left common iliac artery and calcified right cfa bilateral access site.The right access wire was exchanged [otw] for a stiff guidewire during the procedure and when the catheter was withdrawn, the catheter tip became stuck and detached.The left guidewire was also exchanged [otw] for a stiff hydrophilic wire during the procedure and when the second catheter was withdrawn, the catheter tip became stuck and detached as well.Both foreign bodies were successfully snared and removed from the patient with no additional consequences to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is attributed to a weak fuse joint related to the manufacturing process.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 SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18178463
• MDR Text Key: 328611949
• Report Number: 3011642792-2023-00074
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450024928
• UDI-Public: 884450024928
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/14/2023

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 Catalogue Number: 46535BER/B
• Device Lot Number: I2739005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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: STIFF HYDROPHILIC .035; STIFF LUNDERQUIST GUIDEWRIE
• Patient Outcome(s): Required Intervention