MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CENTROS LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	00884450276129
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/04/2021
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 the wire was too stiff when using the device to access the right internal jugular vein.After completion of the procedure, the patient condition worsened and cardiac tamponade occurred.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.Electronic review of the dhr was performed and no similar complaints were identified for this lot number.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: CENTROS LONG TERM HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11338146
• Report Number: 1721504-2021-00008
• Device Sequence Number: 19047126
• Product Code: MSD
• UDI-Device Identifier: 00884450276129
• UDI-Public: 00884450276129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 01/31/2023
• Device Model Number: 00884450276129
• Device Catalogue Number: CENFT23K
• Device Lot Number: H1795005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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