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

Model Number	VST85-35-BD-71S-D1
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A 20- minute procedural delay was reported during a procedure due to the kinking of the versacross steerable sheath while trying to insert the catheter into the patient's groin.The procedure was able to continue after a new versacross steerable sheath was opened and used.While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the resulting procedural delay that occurred.
Additional Manufacturer Narrative
While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.Dhr review was completed for the lot in question, and it was confirmed that all devices met relevant requirements prior to release.

• Brand Name: VERSACROSS STREERABLE 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
• 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: 13982730
• Report Number: 9710452-2022-00017
• Device Sequence Number: 5413021
• Product Code: DYB
• UDI-Device Identifier: 00685447005780
• UDI-Public: (01)00685447005780(17)230820(10)VKFA230321
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• 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): 04/01/2022

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 Expiration Date: 08/20/2023
• Device Model Number: VST85-35-BD-71S-D1
• Device Lot Number: VKFA230321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2021
• 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