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

Lot Number VMFB100423

Device Problems Defective Device (2588); Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text: device not returned to manufacturer.

Event Description

It was reported that during a watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use and patient had a small perforation and blood loss (small retroperitoneal bleed).There was no introducer sheath was used in the groin.Physician dilated with the micropuncture kit dilator at the access site.After gaining right venous access and the mechanical guidewire was advanced up the right iliac and into the right atrium.Then the versacross dilator was inserted into the double curve sheath and advanced into the groin.However, the physician felt resistance and later noted a kink in the guidewire as well distal tip of dilator through fluoroscopy.The iliac vein was very tortuous in this patient.The guidewire was lodged in the dilator so the dilator and wire were removed together.It was noted outside the patient, that a small section of insulation on the guidewire was stripped off.The physician had to wrap the guidewire around hand to pull guidewire out of dilator, distally.An excessive amount of force was needed to remove and ended up breaking the tip of the dilator off.The dilator tip was fully intact inside the patient.Contrast revealed a small venous perforation with dye extravasation.Hence, a non-boston scientific wire was used with the sheath and a series of balloons were used to create tamponade.Heparin was reversed and the perforation closed itself.The procedure was cancelled and patient was kept overnight for observation.It is expected the patient to fully recover.The device is expected to be returned for analysis.

Event Description

It was reported that during a watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use and patient had a small perforation and blood loss (small retroperitoneal bleed).There was no introducer sheath was used in the groin.Physician dilated with the micropuncture kit dilator at the access site.After gaining right venous access and the mechanical guidewire was advanced up the right iliac and into the right atrium.Then the versacross dilator was inserted into the double curve sheath and advanced into the groin.However, the physician felt resistance and later noted a kink in the guidewire as well distal tip of dilator through fluoroscopy.The iliac vein was very tortuous in this patient.The guidewire was lodged in the dilator so the dilator and wire were removed together.It was noted outside the patient, that a small section of insulation on the guidewire was stripped off.The physician had to wrap the guidewire around hand to pull guidewire out of dilator, distally.An excessive amount of force was needed to remove and ended up breaking the tip of the dilator off.The dilator tip was fully intact inside the patient.Contrast revealed a small venous perforation with dye extravasation.Hence, a non-boston scientific wire was used with the sheath and a series of balloons were used to create tamponade.Heparin was reversed and the perforation closed itself.The procedure was cancelled and patient was kept overnight for observation.It is expected the patient to fully recover.There was no introducer sheath was used in the groin.Physician dilated with the micropuncture kit dilator at the access site.Mgw was used due to the leads present, no fluoroscopic imaging was used until resistance was felt during advancement of dilator and sheath.Fluro was then turned on to investigate the root cause of resistance.Echo cardiac imaging was used at access site.It was observed that access of force was applied on the dilator and guidewire assembly inside the patient prior to turning on fluro.The iliac vein was very tortuous in this patient.Mgw was kinked at bend in vein, at the tip of the dilator during dilator advancement.There was no kink prior.To confirm venous perforation at the right iliac vein contrast agent was injected.Ballooning was used mitigate venous perforation (3 balloons used, reaching a size of 18 mm before proving to be effective) it was noted outside the patient, that a small section of insulation on the guidewire was stripped off.The physician had to wrap the guidewire around hand to pull guidewire out of dilator, distally.An excessive amount of force was needed to remove and ended up breaking the tip of the dilator off.The dilator tip was fully intact inside the patient.It was also noted that the dilator tip was very stuck on the guidewire and could not be removed.The device was be returned for analysis.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.

Manufacturer Narrative

The device was returned for analysis.Analysis of the device found based on the information provided in the complaint summary, it is not possible to determine the root cause of the complaint with full certainty.It is possible that the guidewire was kinked or damaged during preparation or initial access (there was extreme iliac tortuosity) thus causing the guidewire to get lodged into the dilator.Complex anatomy could have made it difficult to advance the guidewire and dilator into the svc.The physician may have applied excessive force when advancing the guidewire into the illiac vein, causing it to get kinked and then stuck in the dilator.The guidewire wire returned in 1 piece with coil stacking and numerous kinks.The versacross dilator was advanced over the kinked guidewire which could have resulted in the resistance felt.The reported allegation is confirmed.The cause not established cause code was selected based on the information provided within the event description and return product investigation.The return device and the information within the event description did not have enough information to confirm the cause of the complaint as reported to boston scientific.Supplemental mdr is submitted to report investigation results.Mdr aware date 06sep2023.

• 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: 17550170
• MDR Text Key: 321220346
• Report Number: 2124215-2023-42491
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFB100423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female