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

Lot Number	0033808402
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional 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.A conclusion has yet to be established as the investigation is incomplete.
Event or Problem Description
A perforation and a pericardial effusion (pe) occurred, procedure cancelled.During the procedure, a versacross access solution kit was selected for use for a watchman case.The right femoral vein was accessed, and the versacross rf wire was advanced into the superior vena cava (svc), and the versacross sheath was advanced over the rf wire.Four attempts were made to drop onto the interatrial septum (ias), but were unsuccessfully.Thus, the versacross rf wire was exchanged for the j-tip guidewire.The j-wire was then advanced towards to ias along with the versacross and the physician was able to successfully engaged the septum.The j-wire was the re-exchanged for the versacross rf wire, rf was delivered, and left atrium (la) access was achieved.The wire was then advanced into the left atrial appendage (laa), attempts made to engage the left superior pulmonary vein (lspv) with the versacross wire were unsuccessful.Thus, it was chosen to advance the wire into the right superior pulmonary vein (rspv) instead.The versacross sheath was then used to floss the septum and then exchanged for the watchman single curve sheath.When manipulating the versacross wire and the sheath from the rspv to the laa, the anesthesiologist noted increased fluid buildup in the transverse sinus.A color doppler showed flow from the la into the transverse sinus.The anesthesiologist then performed a pe check and noted a large effusion (transverse sinus and circumferential).The watchman sheath and versacross rf wire were withdrawn from the body, heparin reversed with protamine and pericardiocentesis performed to drain 1800cc of fluid.A 15 min timer was then started to watch the effusion, after which it was noted to no longer be accumulating.The patient was then moved to the intensive care unit (icu) for observation and was expected to fully recover.Prior to the procedure, no pe was noted on echo.The patient was not on warfarin or any antiplatelet drugs at this time.In the physician's opinion, the device did not contribute to the patient complication.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19706198
• Report Number: 2124215-2024-42316
• Device Sequence Number: 6617128
• Product Code: DXF
• UDI-Device Identifier: 00685447011835
• UDI-Public: 00685447011835
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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 Lot Number: 0033808402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/09/2024
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White