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

Catalog Number PC803EU/A

Device Problem Complete Blockage (1094)

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

Event Date 03/19/2021

Event Type  Injury  

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 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.

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
• Type of Device: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11667598
• MDR Text Key: 245490124
• Report Number: 9616662-2021-00008
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00884450013465
• UDI-Public: 884450013465
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: PC803EU/A
• Device Lot Number: K1999939
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention