MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number VMFA120523

Device Problems Defective Device (2588); Device Misassembled During Manufacturing /Shipping (2912); Device-Device Incompatibility (2919); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.The physician gained access from inferior vena cava (ivc) to superior vena cava (svc) by advancing the sheath and dilator over the mechanical guidewire and it got stuck.Hence the entire assembly was pulled out of the body.The wire was then pulled out of dilator and it was noted that it was "shredded/degloved".It was also noted that there was no issue found with the dilator, hence the same dilator was used.The versacross radio frequency wire was then used to complete the procedure successfully.No patient complications occurred.The staff believes that the guidewire packaged is the wrong size causing compatibility issues.Resistance was experienced during loading the mechanical guidewire into the dilator.The device is expected to be returned for analysis.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.The physician gained access from inferior vena cava (ivc) to superior vena cava (svc) by advancing the sheath and dilator over the mechanical guidewire and it got stuck.Hence the entire assembly was pulled out of the body.The wire was then pulled out of dilator and it was noted that it was "shredded/degloved".It was also noted that there was no issue found with the dilator, hence the same dilator was used.The staff believes that the guidewire packaged is the wrong size causing compatibility issues.The versacross radio frequency wire was then used to complete the procedure successfully.No patient complications occurred.The device is expected to be returned for analysis.

Manufacturer Narrative

Supplemental report being submitted to report investigation results (mdr awareness date: 05dec2023).The device was returned for analysis.The pre-decontamination analysis of the device found the guidewire was unraveled.Its core mandrel was fractured near the distal leaving the coil free to stretch.The guidewire remained in one piece.The dilator does not feature a prominent manual curve upon return.The post-decontamination analysis of the device found the guidewire was kinked in two locations approximately at one and two-third of the device length.The j shaped distal tip is no longer visible.The guidewire was within specification during the outside diameter measurement and wire pass tests.The dilator was not within specification during tip pin gage test.The microscope test noted the guidewire exhibited stacked coil at the distal end.It presents multiple sections of coating loss indicative of increased guidewire to dilator contact and friction.The mandrel fracture site is located at the distal j tip.The dilator ro coil is defective from manufacturing process.Two rings of the coil are protruding from the lumen id surface.The tip lumen surface presents notable material loss/inconsistencies.The hypotube distal end does not present visible defect.Hence, the reported allegation is confirmed.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17686046
• MDR Text Key: 322674374
• Report Number: 2124215-2023-46900
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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
• Device Operator: Health Professional
• Device Lot Number: VMFA120523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male