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	07/08/2019
Type of Reportable Event	Serious Injury
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 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.The reported patient complication is an inherent risk in this type of procedure.
Event or Problem Description
The nrg transseptal needle, protrack pigtail wire and torflex transseptal guiding sheath were used in a procedure.A pericardial effusion occurred at the end of the procedure.During transseptal puncture when the physician was tenting the septum, radiofrequency energy was applied and the nrg transseptal needle inadvertently slipped and crossed the septum.Premature ventricular contractions were observed and the physician brought the protrack pigtail wire in through the torflex transseptal guiding sheath.The physician had difficulty getting the protrack pigtail wire to curl.Once both curls had deployed across the septum, the physician brought the torflex transseptal guiding sheath up.No effusion was noted at this time.The protrack pigtail wire was removed and the curl was visually observed to still be intact with no anomalies.At the end of the procedure, a large effusion was noted that resulted in pericardiocentesis with 400cc of blood removed from the heart.The case was noted to be challenging.There is no evidence to suggest that a baylis medical device 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.Separate mdr reports have been submitted for the devices involved.The mfr report numbers for the nrg transseptal needle and protrack pigtail wire are 9710452-2019-00018 and 9710452-2019-00019, respectively.

• 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: 8867691
• Report Number: 9710452-2019-00020
• Device Sequence Number: 2755148
• Product Code: DYB
• UDI-Device Identifier: 00685447000693
• UDI-Public: (01)00685447000693(17)220428(10)TFFA160519
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/06/2019

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: 04/28/2022
• Device Model Number: TF85-32-63-45
• Device Lot Number: TFFA160519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/06/2019
• 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: Required Intervention