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

Model Number	TF85-32-63-45
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as the baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Event or Problem Description
The torflex transseptal guiding sheath was used with a biosense webster ablation catheter during a successful ablation procedure.As the physician removed both the catheter and the sheath following the procedure, a thin translucent material was observed at the tip of the sheath.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as the baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, H4T 1 A1; CA H4T 1A1
• MDR Report Key: 8593729
• Report Number: 9710452-2019-00011
• Device Sequence Number: 1666813
• Product Code: DYB
• UDI-Device Identifier: 00685447000693
• UDI-Public: (01)00685447000693(17)220128(10)TFFA140219
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: TF85-32-63-45
• Device Lot Number: TFFA140219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/08/2019
• 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: Other