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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
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BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION Back to Search Results
Lot Number VMFC061123
Device Problems Defective Device (2588); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported that a versacross connect access solution was selected for use.During the preparation of the device, the scrub tech noticed resistance with trying to advance the versacross dilator into the sheath.Then, with attempting to retract the handle of the versacross dilator snapped off.Looking at the end of the dilator connection it appeared to be a crack (present in the insertion of the dilator to handle).This device was not used in the patient.Therefore, a new device was opened to be used.No patient complications were noted.The procedure was completed successfully.The device is expected to be returned for analysis.The method the device was removed from the package could possibly be the cause, but based on the crack noted is less likely.No excessive force was applied to break the handle off the shaft.No damage noticed prior to inserting into the sheath.It was insured that the removal from tray was removing all plastic covering and lifting up at the hinge point.No other issue was noted.
 
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.
 
Manufacturer Narrative
The device has been received for analysis, but analysis yet not begun.However, due to the media provided, the reported failure was confirmed.Thus, a supplemental mdr is being filed.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 a versacross connect access solution was selected for use.During the preparation of the device, the scrub tech noticed resistance with trying to advance the versacross dilator into the sheath.Then, with attempting to retract the handle of the versacross dilator snapped off.Looking at the end of the dilator connection it appeared to be a crack (present in the insertion of the dilator to handle).This device was not used in the patient.Therefore, a new device was opened to be used.No patient complications were noted.The procedure was completed successfully.The device is expected to be returned for analysis.The method the device was removed from the package could possibly be the cause, but based on the crack noted is less likely.No excessive force was applied to break the handle off the shaft.No damage noticed prior to inserting into the sheath.It was insured that the removal from tray was removing all plastic covering and lifting up at the hinge point.No other issue was noted.
 
Manufacturer Narrative
The device has been received for analysis.Upon receipt at boston scientific's post market laboratory, the device was visually inspected, which revealed that the hub of the dilator has been detached from the shaft.There was clean slit and flaring at end of snap-tip of the hub.The snap tip also had stress marks.Also, it was found a damage on the shaft, approximately 4 mm from the end of the extrusion.Further, the failure was reproduced on an undamaged dilator by using excessive force to bend the dilator.The testing recreated the damage as reported in the complaint and thus confirmed the allegation.This supplemental mdr is being filed to report investigation results (bsc awareness date: 16-apr-2024).Also, a correction to the initial and first supplemental mdr reports sent: e1 (initial reporter address 1 & 2, initial reporter city, initial reporter zip/post code and initial reporter fax).
 
Event Description
It was reported that a versacross connect access solution was selected for use.During the preparation of the device, the scrub tech noticed resistance with trying to advance the versacross dilator into the sheath.Then, with attempting to retract the handle of the versacross dilator snapped off.Looking at the end of the dilator connection it appeared to be a crack (present in the insertion of the dilator to handle).This device was not used in the patient.Therefore, a new device was opened to be used.No patient complications were noted.The procedure was completed successfully.The device is expected to be returned for analysis.The method the device was removed from the package could possibly be the cause, but based on the crack noted is less likely.No excessive force was applied to break the handle off the shaft.No damage noticed prior to inserting into the sheath.It was insured that the removal from tray was removing all plastic covering and lifting up at the hinge point.No other issue was noted.
 
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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 Key18686229
MDR Text Key335137227
Report Number2124215-2024-07930
Device Sequence Number1
Product Code DRE
UDI-Device Identifier00685447012597
UDI-Public00685447012597
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberVMFC061123
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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