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

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

The versacross connect access solution kit has been received at boston scientific's post market laboratory where it is awaiting analysis.Upon 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 the unknown procedure versacross connect access solution kit was selected for use.It has been mentioned that the guidewire was stuck in dilator and bunching of guidewire was visible at distal end.No troubleshooting steps have been mentioned.The procedure outcome is unknown.No patient complications have been reported.The product is expected to be returned.No other issues have been reported.

Manufacturer Narrative

The versacross dilator and mechanical guidewire were received at boston scientific's post market laboratory, and analyzed.During visual inspection, the dilator and guidewire were separated, and the coil did not unfurl.The guidewire was in 1 piece.Kinks are present at the floppy distal end, and a misalignment of the external coil is present at the distal end of the wire.The dilator has been reshaped and kinked.The mechanical guidewire passed the wire other diameter measurement test.From high magnification imaging test, it was noted that the guidewire was showing localized coating wear, indicating an increased contact and friction developed against the dilator lumen.Also, the guidewire was exhibiting overlapping/misaligned coil, and stretched coil.The failure modes were confirmed.The fields e2 (health professional), f10 and h6 (device codes), g1 (mfr site facility name, mfr site address 1, mfr site city, mfr site zip/post code, mfr site country) were also updated.Therefore, this supplemental mdr is being filed.

Event Description

It was reported that during the unknown procedure versacross connect access solution kit was selected for use.It has been mentioned that the guidewire was stuck in dilator and bunching of guidewire was visible at distal end.No troubleshooting steps have been mentioned.The procedure outcome is unknown.No patient complications have been reported.The product is expected to be returned.No other issues have been reported.

• 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 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: 17981298
• MDR Text Key: 326272277
• Report Number: 2124215-2023-57495
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1