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

Model Number	1150-4M200
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	08/30/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Event took place in the us and has been reported through us distributor distribution subsidiary (b)(4).The event has been described initially by another manufacturer potentially involved, abbott.Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.(b)(4).
Event or Problem Description
(b)(4).Description provided by distributor: 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 resuscitative 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 abbott "catheter acunav" - #10135936.Event date: (b)(6) 2019.Account: (b)(6) hospital.Abbott received information from the field regarding the above event.
Additional Manufacturer Narrative
Event took place in the us and has been reported through us distributor distribution subsidiary pajunk medical systems.The event has been described initially by another manufacturer potentially involved, abbott.The initial submission was erroneously submitted as a 5 day report and pajunk gmbh medizintechnologie was not required to initiate action to prevent an unreasonable risk of substantial harm.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.Therefore this report has been re-classified to a 30 day report.Currently the data still is poor and the device has not been returned/ analysed.In case further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
Irn#: (b)(4).Description provided by distributor: 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 comorbitities that contributed to the sequence of events.Before pericardial effusion, the catheter being used before the pajunk needle (#1150-4m200) was the abbott "catheter acunav" - #10135936.Event date: (b)(6) 2019.Account: (b)(6) hospital.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 but on several further parameters.
Event or Problem Description
Irn# (b)(4).Description provided by distributor: 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 comorbitities that contributed to the sequence of events.Before pericardial effusion, the catheter being used before the pajunk needle (#1150-4m200) was the abbott "catheter acunav" - # (b)(6).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 but on several further parameters.
Additional Manufacturer Narrative
Event took place in the us and has been reported through us distributor distribution subsidiary pajunk medical systems.The event has been described initially by another manufacturer potentially involved, abbott.The initial submission was erroneously submitted as a 5 day report and pajunk gmbh medizintechnologie was not required to initiate action to prevent an unreasonable risk of substantial harm.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.Therefore this report has been re-classified to a 30 day report.Currently the data still is poor and the device has not been returned/ analysed.In case further data will be available a follow up report will be sent in to the agency.Based on the analysis of information available file is considered as closed.

• Brand Name: TUOHY NEEDLE
• Common Device Name: 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: 9556364
• Report Number: 9611612-2020-00001
• Device Sequence Number: 2375490
• Product Code: BSP
• UDI-Device Identifier: 14048223022648
• UDI-Public: 14048223022648
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1150-4M200
• Device Catalogue Number: 1150-4M200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/03/2020; 01/03/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/07/2020; 02/19/2020
• 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: Death