MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. FOUNTAIN.INFUSION CATHETER

Catalog Number	FIS4-90-5SQ/JP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an interventional thrombolytic procedure on a patient diagnosed with peripheral vascular disease [pvd], the thrombolytic catheter tip detached within the patient.The physician had acquired arterial access and had successfully negotiated the patients challenging and diseased vasculature under fluoroscopy.The thrombolytic catheter was successfully placed within the patient's superficial fem-pop artery in an attempt to restore patient's blood flow to the lower periphery.During removal of the thrombolytic catheter for follow-up imaging, the tip detached within the patent's lower extremity.The account states that an attempt to retrieve the foreign body in total, may not have been completely successful.Post peripheral vascular intervention, the patient underwent a lower extremity (le) amputation because of the unsuccessful thrombolytic therapy attempts.The account states that the amputation was necessary due to the current disease state of the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually, and functional testing was performed.The area of the break was rough, but not elongated, indicating that the tip was likely caught on something, but did not take much force to break.A definitive root cause could not be determined however, it is likely that significant force was applied to the device 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.

• Brand Name: FOUNTAIN.INFUSION CATHETER
• Common Device Name: INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11787791
• Report Number: 1721504-2021-00026
• Device Sequence Number: 3215208
• Product Code: KRA
• UDI-Device Identifier: 00884450012277
• UDI-Public: 884450012277
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 10/09/2023
• Device Catalogue Number: FIS4-90-5SQ/JP
• Device Lot Number: H1947159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/11/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention