MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL SHEATH; CATHETER INTRODUCER

Model Number	VXS85-35-63-45-D0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as the baylis device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.Tortuous anatomy was a contributing factor to the incident.The reported patient complication is an inherent risk in this type of procedure.
Event or Problem Description
The versacross rf wire was used for transseptal puncture and anchored in the left atrium (la).The physician attempted to dilate the septum with the versacross transseptal sheath and dilator, followed by an evercross dilation catheter.Pericardial effusion occurred during the septum dilation.Due to the pericardial effusion, the case was aborted.A pericardial tap was performed and the patient was sent to recovery.Tortuous anatomy was a contributing factor to occurrence of the effusion.There is no evidence to suggest that a baylis medical device caused or contributed to the reported incident.However, as baylis medical device were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• MDR Report Key: 9708194
• Report Number: 9710452-2020-00005
• Device Sequence Number: 19751605
• Product Code: DYB
• UDI-Device Identifier: 00685447003380
• UDI-Public: (01)00685447003380(17)200812(10)VXFA251019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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 Expiration Date: 08/12/2020
• Device Model Number: VXS85-35-63-45-D0
• Device Lot Number: VXFA251019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/13/2020
• 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: Required Intervention