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

Catalog Number	465356MHK-NB
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a peripheral vascular procedure, a catheter tip detached within the patient.The physician had successfully acquired retrograde arterial access and had negotiated the patient's ilio-femoral conduit with an interventional guidewire and 4f catheter.The physician states that during a difficult catheter removal process, from the patient's common iliac artery the catheter hub detached.Additional attempts in removing the catheter from the patient resulted in catheter tip detachment as well.Removal of the remaining catheter was not difficult.The physician exchanged the primary sheath for a longer 6f secondary sheath for foreign body removal.The sheath was advanced over the detached foreign body successfully and removed liberating the patient's iliac conduit.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Only the catheter hub and tip returned for investigation.Since the device arrived damaged according to the incident description, the complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the catheter during clinical use.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 were identified.Corrective actions are in progress.

• Brand Name: IMPRESS®. CATHETER
• Common Device Name: INTRAVASCULAR, DIAGNOSTIC CATHETER
• 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: 13640690
• Report Number: 3010665433-2022-00021
• Device Sequence Number: 2187533
• Product Code: DQO
• UDI-Device Identifier: 00884450023198
• UDI-Public: 884450023198
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 11/16/2024
• Device Catalogue Number: 465356MHK-NB
• Device Lot Number: E2291297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (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: AMPLATZ GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown