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

Catalog Number	59038UAC
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number has been provided and a review of the manufacturing history record is in progress.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The customer alleges that during a uterine artery embolization angiogram, the catheter tip detached.The physician had acquired ipsilateral retrograde femoral artery access and had negotiated the patient's contralateral ilio-femoral conduit with a 5f guide catheter and guide wire under fluoroscopy guidance.During a small injection of contrast, identifying the actual location of the catheter tip within the patient's anatomy unexpectedly confirmed that the catheter tip detached within the patient's arterial vascular system.The physician attempted to use a vascular snare device to successfully externalize the foreign body as it fragmented again into three additional pieces that further migrated within the patient's periphery.The foreign bodies had migrated to the patient's femoral, popliteal, and anterior tibial arteries.Medical intervention was necessary to remove the foreign bodies from within the patient's contralateral vascular system.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A photograph was provided by the account.The complaint is 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 one similar complaint for this lot number was identified.

• Brand Name: .IMPRESS®.BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• 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: 16135284
• Report Number: 3010665433-2023-00006
• Device Sequence Number: 17846717
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2024
• Device Catalogue Number: 59038UAC
• Device Lot Number: E2116874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown