MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE TUOHY NEEDLE; NERVE BLOCK NEEDLE, EPIDURAL SINGLE SHOT AND CATHETER PLACEMENT

Model Number 1150-4M200

Device Problem Off-Label Use (1494)

Patient Problem Death (1802)

Event Date 08/30/2019

Event Type  Death  

Manufacturer Narrative

The event has been described initially by another manufacturer potentially involved, abbott.Based on the information received, this incident (death of a patient) is not related to a defective device manufactured by pajunk gmbh medizintechnologie but on several further parameters.No report of device malfunction received.Report # 9611612-2020-00001 has been submitted by the device manufacturer.Currently no further information is available and the device has not been returned/ analysed.In case further data becomes available, a follow up report will be sent in to the agency.

Event Description

The following report of an adverse event was provided to pajunk medical systems on january 3, 2020: an adverse event report was received, in which your device was involved.Event description: during a ventricular tachycardia ablation procedure, a pleural effusion, cardiac arrest and subsequent death occurred.While attempting epicardial access, a pleural effusion was confirmed on ice at the rv apex, suggestive perforation from the pajunk needle.Epicardial access was confirmed with dye visualized layering around the pericardial space.A wire was then advanced and observed to curl in the epicardial space without advancing beyond the cardiac silhouette.An agilis sheath was then advanced over the wire into the pericardial space.A second wire was advanced into the epicardium.The agilis was removed and advanced over one of the wires.The wire and dilator were from the agilis and the remaining wire was secured to the drape.Approximately 290 cc of blood was removed from the pericardial space.The effusion did not reaccumulate and was closely monitored during the procedure.A coronary angiogram was completed afterwards.Following the ablation, the patient became hypotensive.Blood was visualized in the pericardial space.Chest compressions were initiated.A chest tube was placed and a blood was removed.The bleeding did not slow and ct surgery was called for ecmo.The rhythm degenerated and the patient chocked multiple times throughout.Sinus rhythm could not be restored.Surgery was performed and biv pacing was finally restored after heart paddle shock.Direct visualization of the heart showed the left-sided chest tube was puncturing the lv.The chest tube was removed and the myocardium was stitched.Bleeding could not cease and resusitive efforts were abandoned.The patient was deceased.It was noted the patient was high-risk with comorbidities that contributed to the sequence of events.Before pericardial effusion, the catheter being used before the pajunk needle (#1150-4m200) was the "catheter acunav" - #10135936.Event date: (b)(6) 2019.Account: (b)(6).Abbott received information from the field regarding the above event.Based on the information above this incident is not related to a defective device manufactured by pajunk gmbh medizintechnologie (device manufacturer) but on several other parameters.A medwatch report was submitted by the manufacturer as well.

• Brand Name: TUOHY NEEDLE
• Type of Device: NERVE BLOCK NEEDLE, EPIDURAL SINGLE SHOT AND CATHETER PLACEMENT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9566604
• MDR Text Key: 174265356
• Report Number: 3004076349-2020-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223022648
• UDI-Public: 14048223022648
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2020,01/08/2020

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
• Device Operator: Health Professional
• Device Model Number: 1150-4M200
• Device Catalogue Number: 1150-4M200
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death