MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VLA125-35-67-D1
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A procedural delay was reported in a case where the versacross large access transseptal dilator (vla) was used in a transseptal procedure.A 0.035 j tip guidewire was placed in the superior vena cava (svc), followed by advancement of the vla over the guidewire.When the physician attempted to track up to the svc, resistance was encountered.The physician had difficulty maneuvering the devices and the guidewire was damaged while it was being pulled back into the vla.The devices were removed from the patient's body and the transseptal access was completed successfully using the versacross transseptal sheath and versacross rf wire.There was no patient injury reported.However, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay that occurred.
Additional Manufacturer Narrative
There was no patient impact or consequence.Baylis medical company inc.Has decided to report this event due to the procedural delay that occurred.Dhr review was completed for the lot in question and all the devices fulfilled all requirements prior to release.

• Brand Name: VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 13237738
• Report Number: 9710452-2022-00001
• Device Sequence Number: 11839190
• Product Code: DRE
• UDI-Device Identifier: 00685447005254
• UDI-Public: (01)00685447005254(17)240302(10)VLFA270721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VLA125-35-67-D1
• Device Lot Number: VLFA270721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown