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

Model Number VXS85-35-63-45-D0

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

Patient Problem Pericardial Effusion (3271)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

Event Description

A case of pericardial effusion was reported in a procedure where the versacross rf wire and versacross transseptal sheath were used among other devices, including the watchman delivery sheath and amplatzer pfo occluder.Successful transseptal puncture was completed using the versacross rf wire and the versacross transseptal sheath.The watchman delivery sheath was advanced into the left atrium following removal of the versacross transseptal sheath.The versacross rf wire was removed and the amplatzer pfo occluder was implanted.A pericardial effusion sweep was performed, and an effusion was noted.The patient was stabilized.There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A separate mdr has been submitted for the versacross rf wire under mfr report number: 3019751610-2022-00016.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 15117481
• MDR Text Key: 296748449
• Report Number: 3019751610-2022-00017
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

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 Model Number: VXS85-35-63-45-D0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other