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

Catalog Number	PC803EU/A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an emergent percutaneous pericardiocentesis for life threatening cardiac tamponade, the drainage catheter could not be successfully introduced.The physician used a local anesthetic to numb the access area [ subxiphoid approach] of the patient's chest.A needle was then inserted, via "seldinger technique", under the guidance of an echo/fluoroscopy, into the patient's pericardial sack.A guidewire was inserted into the patient pericardium and the access needle successfully removed.When the physician tried to introduce the drainage catheter, over the "j" wire into the patient's pericardium, the drainage catheter would not allow the access wire through the catheter's inner limen.The account alleges that the distal part of the drainage catheter was obstructed.Another catheter was expeditiously prepped and successfully used to treat this patient.The patient tolerated the procedure well with no additional consequences to report.
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: PERICARDIOCENTESIS CATHETER
• Common Device Name: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11667598
• Report Number: 9616662-2021-00008
• Device Sequence Number: 3052193
• Product Code: GBX
• UDI-Device Identifier: 00884450013465
• UDI-Public: 884450013465
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 08/31/2023
• Device Catalogue Number: PC803EU/A
• Device Lot Number: K1999939
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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; Life Threatening; Required Intervention