MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. FOUNTAIN®; CATHETER, CONTINUOUS FLUSH

Model Number 00884450011676

Device Problems Fracture (1260); Material Separation (1562); Material Twisted/Bent (2981)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

The account alleges that during an elective procedure for peripheral arterial occlusion between right femoral and popliteal arteries the wire broke while removing.Although the vessels had calcification, no significant tortuosity has not been found.Contralateral approach from left femoral artery was used for the procedure.After the completion of the infusion with the influsion catheter, the occluding wire was attempted to be withdrawn, leaving the infusion catheter in the vessel.At this time, the operator felt physical resistance at the vicinity of a y-connector at the operator's [proximal] end of the product.However, the operator pulled the wire out, and the wire got broken off.The breakage site was more proximal to the ball at the tip of the wire.The entire portion of the wire was withdrawn out with theinfusion catheter, deeming that the ball with the broken portion of the wire would not transfer into patient's body from the catheter tip.After the withdrawal, it was found that the catheter had kinked.The kink was not found before use.The planned procedure was completed.No patient injury to report.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during use.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: FOUNTAIN®
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15331357
• MDR Text Key: 305374587
• Report Number: 1721504-2022-00079
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00884450011676
• UDI-Public: 00884450011676
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K974067
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450011676
• Device Catalogue Number: FIS4-135-50SQ/JP
• Device Lot Number: H2403530S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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