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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
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2023
Event Type  malfunction  
Event Description
It was reported that during a watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The mechanical j-wire was placed into superior vena cava (svc).Then the watchman sheath and versacross dilator was positioned in superior vena cava (svc).When the wire was attempted to be removed, it got stuck and could not be advanced or retracted.Therefore, both the dilator and wire were removed and replaced with the new system.The procedure was completed successfully and no patient complications reported.The device is expected to be returned for analysis.It was further noted there were no issues upon removal from packaging.It is suspected that the wire may have kinked when bringing the dilator/sheath up the tortuous anatomy.The guidewire distal end protruding from dilator.The watchman sheath remained in the body and was not replaced.
 
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
Supplemental mdr submitted to report investigation results (mdr aware date: 26oct2023).The device was returned for analysis.The guidewire wire returned in one piece with coil stacking and numerous kinks.The versacross dilator was also severely kinked at the distal tip.This issue of mechanical guidewire to versacross dilator compatibility/stuck was investigated as part of capa.
 
Event Description
It was reported that during a watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The mechanical j-wire was placed into superior vena cava (svc).Then the watchman sheath and versacross dilator was positioned in superior vena cava (svc).When the wire was attempted to be removed, it got stuck and could not be advanced or retracted.Therefore, both the dilator and wire were removed and replaced with the new system.The procedure was completed successfully and no patient complications reported.The device is expected to be returned for analysis.It was further noted there were no issues upon removal from packaging.It is suspected that the wire may have kinked when bringing the dilator/sheath up the tortuous anatomy.The guidewire distal end protruding from dilator.The watchman sheath remained in the body and was not replaced.
 
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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, 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 Key17568130
MDR Text Key321444127
Report Number2124215-2023-43655
Device Sequence Number1
Product Code DRE
UDI-Device Identifier00685447012580
UDI-Public00685447012580
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
Report Date 11/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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