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

Model Number VXS85-35-63-45-D1

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

Patient Problem Pericardial Effusion (3271)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

Event Description

The versacross rf wire and the versacross transseptal sheath were used for transseptal puncture during a cryo ablation procedure.Upon successful transseptal puncture, the physician exchanged the versacross transseptal sheath with the cryo sheath and dilator.The physician attempted to dilate the septum further using the cryo dilator but the cryo sheath was unable to cross.The cryo sheath and dilator were removed and the expansure large access transseptal dilator was used in an attempt to further dilate the septum.The cryo sheath and dilator were attempted again but was again unsuccessful.During preparation for a second transseptal puncture, the devices were removed from the left atrium and a drop of pressure was observed.A pericardial effusion was observed on fluoroscopy and a pericardial effusion tap protocol was initiated.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 problem report has been submitted for the versacross rf wire and expansure large access transseptal dilator under mfr report number: 3019751610-2022-00015 and 3019751610-2022-00013.

• 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: 15031427
• MDR Text Key: 296007648
• Report Number: 3019751610-2022-00014
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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-D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• 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): Required Intervention