MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. TORFLEX TRANSSEPTAL GUIDING SHEATH; CATHETER INTRODUCER

Model Number	TF85-32-63-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional 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 failure.
Event or Problem Description
A case of pericardial effusion was reported during a procedure where the versacross rf wire, versacross transseptal sheath, nrg transseptal needle and torflex transseptal guiding sheath were used.The patient had an existing pericardial effusion that grew during the procedure due to a suspected right atrium puncture.The procedure was aborted and a pericardiocentesis was performed.The patient stabilized and was kept overnight.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.Separate problem reports have been submitted for the versacross transseptal sheath, versacross rf wire and nrg transseptal needle.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• MDR Report Key: 11278201
• Report Number: 9710452-2021-00004
• Device Sequence Number: 19844846
• Product Code: DYB
• UDI-Device Identifier: 00685447000693
• UDI-Public: (01)00685447000693(17)230909(10)TFFP200820
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K102948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: TF85-32-63-45
• Device Lot Number: TFFP200820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention