MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PROGUIDE CHRONIC DIALYSIS CATHETER

Model Number	00884450023426
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
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 and attempted dialysis treatment procedure, the endcaps detached from the catheter.The patient had the dialysis catheter placed at the same facility on (b)(6) 2020.The patient's anatomy was extremely challenging during placement.During attempts to remove the end caps from the catheter on (b)(6) 2020 at the dialysis center, the caps became stuck.During additional removal attempts, the catheter hub detached from the catheter.The patient was doing fine and was sent to a local hospital for a new catheter exchange because the dialysis center was closing.The patient was an out-patient in radiology, the catheter was re-wired, and a new catheter was placed.No patient injury to report.Patient tolerated this procedure well.Dialysis was completed the next morning at the center without additional consequences to the patient.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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: PROGUIDE CHRONIC DIALYSIS CATHETER
• Common Device Name: CHRONIC DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• MDR Report Key: 9857536
• Report Number: 1721504-2020-00013
• Device Sequence Number: 3307924
• Product Code: MSD
• UDI-Device Identifier: 00884450023426
• UDI-Public: 00884450023426
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 00884450023426
• Device Catalogue Number: DC21452419/A
• Device Lot Number: H1671893
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1