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

Lot Number VMFD290523

Device Problems Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It has been reported that a versacross connect access solution kit was selected for use for a watchman flx procedure.During preparation, the physician mentioned that the side hub on the dilator broke off.No photo available and not damage was noted to the dilator packaging or the dilator itself prior to use.A new kit was opened and the procedure was completed successfully (different device, same model).No patient complications reported.The product is not expected to return as it was discarded at the facility.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is anyfurther relevant information obtained, a supplemental medwatch will be filed.16oct2023: gfe response received - it has further been mentioned that the damage that occurred did not allow air into the system but it is unable to be confirmed if it would have during procedure; therefore, the complaint remains reportable.Also, no damage was noted to the dilator packaging or the dilator itself prior to use.

Event Description

It has been reported that a versacross connect access solution kit was selected for use for a watchman flx procedure.During preparation, the physician mentioned that the handle of the dilator (curve indicator) broke off.A new kit was opened and the procedure was completed successfully (different device, same model).No patient complications reported.The product is not expected to return as it was discarded at the facility.

Manufacturer Narrative

Additional information received on 01-nov-23 confirmed that it was the handle of the dilator (curve indicator) that broke off and not the main hub.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considered this to be a reportable event.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 17980525
• MDR Text Key: 326292365
• Report Number: 2124215-2023-57628
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• 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: 11/30/2023

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: VMFD290523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Sex: Male