MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Shock (2072); Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440)

Event Date 08/30/2023

Event Type  Death  

Event Description

It was reported that a patient death occurred.A versacross access solution was selected for use during a left atrial appendage (laa) closure.The patient was not on any anticoagulation prior to the procedure.The physician struggled to dilate the left femoral vein with the versa cross connect system, but the vein was ultimately dilated using the dilator of the versacross connect.When the versacross connect wire was advanced from the femoral vein to the inferior vena cava, it was noticed there was a kink at the distal end.Thus, a new rf wire (versacross access system) was opened and used along with the dilator from versacross connect, attempting to access the interatrial septum with the versa cross connect 2-3 times.Thus, the versacross connect system was replaced with versacross access system and the septum was crossed (entire versacross access), and versacross rf wire was placed in the left upper pulmonary vein.During the tsp approach, the echocardiogram physician noticed something near the fossa and possibly on the versacross catheter.The echocardiogram physician concluded that the object was reverberations from the catheter and the pacemaker wires.When the versacross connect system was removed from the patients anatomy, the distal tip was observed to be damaged.The versacross connect system was then flushed and small clots flushed out of the system.The laa was accessed with a pigtail catheter.A watchman access system was advanced and positioned and a 27mm watchman flx closure device and delivery system (wds) was advanced and deployed.The echocardiogram physician made a note of the patient's blood pressure.The wds was recaptured.During recapture, the physician encountered difficulty keeping the core wire stable while advancing the sheath over the face and shoulders of the closure device.Release criteria was reviewed, and the compression was noted at 29-33%.The wds was released.After release, compression was re-measured at 28-31%.An effusion sweep was performed revealing no pericardial effusion.Post-procedure, the patient was alert after extubating.Approximately one-hour post-procedure, the patient became short of breath and was reintubated.The patient decompensated, experiencing cardiac arrest with pulseless electrical activity for 30 minutes followed by ventricular fibrillation and shock.A check was performed for pericardial effusion, which was clear.The patient received cardiopulmonary resuscitation, defibrillation, and a transfusion.Despite efforts, the patient died.The official cause of death was cardiac arrest.In the physicians opinion, no boston scientific device is related to death, since a pericardial effusion was check and it was negative during the code.One of contributing factors could be a cad - coronary artery disease.The act was between 200 and 250, but the physician had already given 20,000 units of heparin.The versacross system was in inferior vena cava (ivc) when it was noted difficulty dilating the left femoral vein due to the patient's body habitus.Both radio frequency wire involved believed to be 230 cm length.It did not have as much bend in the distal end after multiple attempts to dilate the vein and could not make contact to tent the fossa during the several attempts to cross.When versacross devices were removed from body, the distal tip of the dilator tip was damaged and clots were noted.No perforation reported.There were multiple attempts required to track up / drop down into position on septum before tsp was performed.No issues noted with radio frequency wire tenting.It is not believed the wire malfunctioned during procedure.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a patient death occurred.A versacross access solution was selected for use during a left atrial appendage (laa) closure.The patient was not on any anticoagulation prior to the procedure.The physician struggled to dilate the left femoral vein with the versa cross connect system, but the vein was ultimately dilated using the dilator of the versacross connect.When the versacross connect wire was advanced from the femoral vein to the inferior vena cava, it was noticed there was a kink at the distal end.Thus, a new rf wire (versacross access system) was opened and used along with the dilator from versacross connect, attempting to access the interatrial septum with the versa cross connect 2-3 times.Thus, the versacross connect system was replaced with versacross access system and the septum was crossed (entire versacross access), and versacross rf wire was placed in the left upper pulmonary vein.During the tsp approach, the echocardiogram physician noticed something near the fossa and possibly on the versacross catheter.The echocardiogram physician concluded that the object was reverberations from the catheter and the pacemaker wires.When the versacross connect system was removed from the patients anatomy, the distal tip of the versacross connect dilator was observed to be damaged.The versacross connect system was then flushed and small clots flushed out of the system.The laa was accessed with a pigtail catheter.A watchman access system was advanced and positioned and a 27mm watchman flx closure device and delivery system (wds) was advanced and deployed.The echocardiogram physician made a note of the patient's blood pressure.The wds was recaptured.During recapture, the physician encountered difficulty keeping the core wire stable while advancing the sheath over the face and shoulders of the closure device.Release criteria was reviewed, and the compression was noted at 29-33%.The wds was released.After release, compression was re-measured at 28-31%.An effusion sweep was performed revealing no pericardial effusion.Post-procedure, the patient was alert after extubating.Approximately one-hour post-procedure, the patient became short of breath and was reintubated.The patient decompensated, experiencing cardiac arrest with pulseless electrical activity for 30 minutes followed by ventricular fibrillation and shock.A check was performed for pericardial effusion, which was clear.The patient received cardiopulmonary resuscitation, defibrillation, and a transfusion.Despite efforts, the patient died.The official cause of death was cardiac arrest.In the physicians opinion, no boston scientific device is related to death, since a pericardial effusion was check and it was negative during the code.One of contributing factors could be a cad - coronary artery disease.The act was between 200 and 250, but the physician had already given 20,000 units of heparin.The versacross system was in inferior vena cava (ivc) when it was noted difficulty dilating the left femoral vein due to the patient's body habitus.Both radio frequency wire involved believed to be 230 cm length.It did not have as much bend in the distal end after multiple attempts to dilate the vein and could not make contact to tent the fossa during the several attempts to cross.When versacross devices were removed from body, the distal tip of the dilator tip was damaged and clots were noted.No perforation reported.There were multiple attempts required to track up / drop down into position on septum before tsp was performed along with versacross connect kit and versacross access solution kit.No issues noted with radio frequency wire tenting.It is not believed the wire malfunctioned during procedure.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.The fields b5 (describe event or problem), f10 and h6 (device codes) were updated.Thus, a supplemental medwatch is being filed.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17839460
• MDR Text Key: 324530940
• Report Number: 2124215-2023-51546
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/14/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White