MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number VMFG120523

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 08/16/2023

Event Type  Injury  

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 pericardial effusion occurred and the procedure was aborted.A left atrial appendage (laa) closure procedure was being performed.A versacross connect catheter was loaded into a double curve watchman fxd curve access system (was), and transseptal puncture was performed.A j tip guidewire was used as the starter wire.The was advanced into the superior vena cava (svc), and the j tip guidewire was exchanged for a versacross pigtail rf wire.The devices dropped down into the right atrium (ra) for transseptal puncture.During the first drop down, the was difficult to see on echocardiography.Multiple maneuvers were performed to tent the septum; however, the tenting of the septum could not be visualized on echocardiography.The echocardiography imager noted that the was too posterior in position.After counter clocking the was, there was no change.The physician tried to push the versacross pigtail rf wire out.The versacross pigtail rf wire fully formed and did not appear in the left atrium (la).The physician pulled out as the devices went transseptal.The devices were rewired into the svc and dropped the devices back down to the septum, successfully engaging the fossa.The versacross pigtail rf wire was anchored into the left upper pulmonary vein (lupv), and the dilator and wire were exchanged for the pigtail catheter.The non-boston scientific pigtail catheter was anchored to the laa, and contrast was given.A 31mm watchman closure device & delivery system (wds) were then selected.Three deployments were attempted with the 31mm closure device; however, the shoulder was either too large or the device pinched.Echocardiography showed a small pericardial effusion at the time of the removal of the 31mm closure device.Seven deployments of a 27mm closure device were then attempted, however, the 27mm closure device was under-compressed and failed the tug test.The pericardial effusion grew multiple times while the 27mm closure device was being assessed.The procedure was aborted to treat the pericardial effusion.The pericardial effusion was most visible around the right ventricle.Pericardiocentesis was performed to drain the pericardial effusion.The patient was stabilized, and a cell saver was used to recycle the patient's blood.The echocardiography imager extubated the patient after confirming the patient was in stable condition.The patient fully recovered from this event and was discharged home.The physician believes either the versacross connect went transseptal at an unsafe location or multiple recaptures with the watchman device caused the pericardial effusion, but no malfunction was noted along with versacross devices.No radio frequency was delivered during the first attempt.The physician noted that the was sheath was mid and very posterior but out of view on short axis, thus the physician repositioned the was sheath by counter clocking but the sheath did not appear at all on the short axis view.He was at 3 o clock at one point.The physician pushed the versacross rf wire out after deciding to restart the drop down, and then a glimpse of the wire was saw in the la.Fluoro imaging seemed to confirm la access as well.The conclusion was that the dilator mechanical crossed in the la.The tenting on bicaval view seemed normal.No difficulty with imaging/visualizing the versacross rf wire was noted, but a positioning issue.The patient was under elliquis during the procedure.The device is not expected to be returned for analysis.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 17726615
• MDR Text Key: 323157228
• Report Number: 2124215-2023-49085
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• 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
• Report Date: 09/11/2023

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
• Device Lot Number: VMFG120523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female