MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERICARDIOCENTESIS CATHETER; IRRIGATION CATHETER

Catalog Number	502368001
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not 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 emergent pericardiocentesis procedure, it was stated that the catheter was too soft.The patient was hemodynamically unstable and diagnosed with cardiac tamponade at the time.The catheter was discarded, and a new kit was opened and used to complete this procedure for the patient.
Additional Manufacturer Narrative
The suspect device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.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.Should the device be returned later, the investigation will be re-opened.

• Brand Name: PERICARDIOCENTESIS CATHETER
• Common Device Name: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 14652208
• Report Number: 3010665433-2022-00056
• Device Sequence Number: 5693417
• Product Code: GBX
• UDI-Device Identifier: 00884450013465
• UDI-Public: 884450013465
• Combination Product (Y/N): N
• Initial Reporter Country: SL
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 502368001
• Device Lot Number: E2242874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown