MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERCARDIOCENTESIS KIT.STERILE; CUSTOM KIT

Catalog Number	PC801
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
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 review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that a pericardiocentesis procedure was performed at patient's bedside within the unit for subacute cardiac tamponade.The physician failed to acquire access to the patient's pericardium with the 8.3f pigtail catheter.The physician had a difficult time advancing the drainage catheter to the pericardium over-the-access wire.The physician had to use additional force with the dilator/guidewire which possibly resulted in the puncture/perforation of the patient's right ventricle.The account agrees that an inadequate number of dilators were available to properly dilate the pericardium due to the fact this procedure was performed at patient's bed side and not in cathlab setting.The patient was transferred to surgical unit for urgent thoracotomy after right ventricular perforation.Patient was doing well two weeks post-surgical follow up.Device was discarded and will not be returning for evaluation.The reporting nurse states that this patient has a history of radiation therapy to chest that would have caused a lot of scar tissue/fibrous tissue formation resulting in extreme difficulty in acquiring access during pericardiocentesis attempts.Historically, difficult access to the pericardium has been a factor with this patient.

• Brand Name: PERCARDIOCENTESIS KIT.STERILE
• Common Device Name: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• MDR Report Key: 12174199
• Report Number: 1125782-2021-00002
• Device Sequence Number: 1622260
• Product Code: PXU
• UDI-Device Identifier: 00884450054017
• UDI-Public: 884450054017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PC801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 07/15/2021
• 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