MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERITMEDICAL; ANGIOGRAPHIC PIGTAIL CATHETER

Catalog Number 7529-23/B

Device Problem Misassembly by Users (3133)

Patient Problem Brain Injury (2219)

Event Date 05/02/2021

Event Type  Death  

Event Description

A straightener was mis-threaded back onto a pigtail catheter during a percutaneous thromboembolectomy resulting in the straightener not peeling off as designed when it was reinserted into the sheath.It remained flat on the catheter during a subsequent reinsertion which allowed it to be fully inserted into the sheath where it ultimately migrated off of the device into the patient's circulation and to the pericardium creating a cardiac tamponade.The patient experienced a cardiac arrest and coded until blood was extracted from the pericardium.The patient never regained meaningful neurological function after the event and was placed into hospice with comfort care two weeks prior to expiring.The mfr was notified of the event on 05/03/2021.

• Brand Name: MERITMEDICAL
• Type of Device: ANGIOGRAPHIC PIGTAIL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. ; south jordan UT 84095
• MDR Report Key: 12094343
• MDR Text Key: 259256247
• Report Number: 12094343
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7529-23/B
• Device Lot Number: I1911739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2021
• Distributor Facility Aware Date: 05/02/2021
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A 20FRENCH INARI CATHETER ; A GLIDECATH ; A JR4 CATHETER; AN AMPLATZER WIRE ; ENDOTRACHEAL INTUBATION ; MODERATE SEDATION
• Patient Outcome(s): Death
• Patient Age: 44 YR
• Patient Weight: 85