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

Model Number VXS85-35-63-45-D0

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

Patient Problem Heart Block (4444)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

There is no suspected device failure.

Event Description

A case of complete heart block was reported in a procedure where the versacross transseptal sheath was used.Due to positioning of the dilator, inadvertent contact was made by dilator with the av node during advancement in the ivc and up to the right atrium.Chest compression was carried out and the procedure was resumed after a 10-minute delay.There is no suspected device failure.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Type of Device: CATHETER, INTRODUCER
• 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: 11822499
• MDR Text Key: 252226332
• Report Number: 9710452-2021-00033
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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
• Date Manufacturer Received: 04/26/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention