MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND PERICARDIOCENTESIS KIT; IRRIGATION CATHETER

Catalog Number PC803EU

Device Problems Device Operational Issue (2914); Physical Property Issue (3008)

Patient Problem Pericardial Effusion (3271)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an emergent pericardiocentesis the drainage catheter buckled on the guidewire during access.The patient was hemodynamically compromised and unstable at the time the pericardiocentesis was attempted.The physician was having a difficult time in getting the drainage catheter into the pericardial sac of the heart.It would not advance far enough into the pericardium and the drainage catheter kept buckling.The physician had no choice but to use another catheter to relieve the pressures from the patient's pericardial sac.The competitor's catheter was successful in relieving the pressure that was depriving the heart of its ability to perfuse the organs of the body.The patient has recovered.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: PERICARDIOCENTESIS KIT
• Type of Device: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• MDR Report Key: 7580414
• MDR Text Key: 110447666
• Report Number: 1125782-2018-00023
• Device Sequence Number: 1
• Product Code: GBX
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PC803EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR