MAUDE Adverse Event Report: VERSACROSS TRANSSEPTAL SHEATH; CATHETER, INTRODUCER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

A case of complete heart block was reported during a procedure where the versacross transseptal sheath was used.During drop down, the sheath was sliding inferior due to aneurysmal septum.The pulling back of the sheath caused it to put pressure on the atrioventricular node leading to the heart block.

Manufacturer Narrative

There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device malfunction.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Type of Device: CATHETER, INTRODUCER
• MDR Report Key: 12731582
• MDR Text Key: 281861270
• Report Number: 9710452-2021-00049
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K183655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening