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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL SHEATH INTRODUCER, CATHETER

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BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL SHEATH INTRODUCER, CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)
Event Date 07/28/2022
Event Type  Injury  
Manufacturer Narrative
There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident. However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
 
Event Description
A case of cardiac tamponade requiring intervention was reported during a left-atrial appendage closure (laac) procedure where the versacross transseptal sheath (vxs) and versacross rf wire (vxw) were used for the initial transseptal puncture. During the transseptal workflow, the physician experienced challenges visualizing tenting of the septum. Following manipulation and reintroduction of the device assembly, tenting was observed and transseptal puncture with delivery of rf energy was achieved. However, the vxw was not observed in the left atrium. A pericardial effusion was noted, and the patient's blood pressure dropped. Shortly after, cardiac tamponade occurred. Chest compressions and pericardiocentesis was completed and the patient was stabilized. An arterial line was placed and the patient was continuously monitored. Approximately 15 minutes later, the patient's blood pressure dropped again and a blood transfusion was required. The patient was admitted to the icu for recovery. There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident. However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report. A separate mdr has been submitted for the versacross rf wire under mfr report number: 3019751610-2022-00024.
 
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Brand NameVERSACROSS TRANSSEPTAL SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BAYLIS MEDICAL COMPANY INC.
5959 trans-canada highway
montreal, quebec H4T 1 A1
CA H4T 1A1
Manufacturer (Section G)
BAYLIS MEDICAL COMPANY INC.
2775 matheson blvd. east
mississauga, ontario L4W 4 P7
CA L4W 4P7
Manufacturer Contact
meghal khakhar
2775 matheson blvd. east
mississauga, ontario L4W 4-P7
CA   L4W 4P7
MDR Report Key15332445
MDR Text Key299037096
Report Number3019751610-2022-00025
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183655
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/31/2022 Patient Sequence Number: 1
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