MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. SUREFLEX STEERABLE GUIDING SHEATH; CATHETER INTRODUCER

Model Number	TSK85-32-BD-71M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/12/2020
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.A review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.
Event or Problem Description
During a ventricular tachycardia ablation procedure using the sureflex steerable guiding sheath, epstar fixed electrophysiology catheter, terumo guide catheter and deca catheter, the procedure was aborted due to pericardial effusion requiring intervention.The patient was stabilized and eventually discharged.There is no evidence to suggest the baylis medical devices caused or contributed to the reported complications.However, as baylis devices were among the several devices used in the procedures, baylis medical has decided to submit this report.A separate medical device problem report has been submitted for the epstar fixed electrophysiology catheter.

• Brand Name: SUREFLEX STEERABLE 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: 10817118
• Report Number: 9710452-2020-00032
• Device Sequence Number: 2113850
• Product Code: DYB
• UDI-Device Identifier: 00685447004615
• UDI-Public: (01)00685447004615(17)220728(10)SSFC250719
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122926
• 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): 11/10/2020

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: 07/28/2022
• Device Model Number: TSK85-32-BD-71M
• Device Lot Number: SSFC250719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/10/2020
• 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