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

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

Patient Problem Cardiac Tamponade (2226)

Event Type  Death  

Event Description

During a literature review, an article [1] was identified with the following information: "tsp was performed initially with a mechanical needle and sheath assembly (mullins transseptal needle, cook medical, bloomington, in, usa) and later in the experience with a radiofrequency needle system (torflex transseptal guiding sheath; nrg transseptal needle; baylis medical, burlington, ma, usa).The transseptal dilator and sheath were advanced to the left atrium, the needle removed, and an 0.025[?] pigtail wire (protrack, baylis medical) was inserted through the needle and positioned in the left atrium, after which the steerable guide (sg) catheter was advanced over the wire and across the septum.Procedural complications related to tsp included pericar-dial effusion (n = 3, 3% of 107), all of which resolved spontaneously, and cardiac tamponade (n = 1, 1% of 107), which was managed by sternotomy followed by off- pump repair of a bleeding site in the right atrium.Five patients died prior to discharge (5% of 107), and of the remaining patients, 82 were discharged home and 20 were discharged to extended- care facilities.Thirty- day mortality was 8% (8 of 107 patients)." there is no evidence to suggest that the baylis medical devices caused or contributed to the reported complications.However, as baylis medical devices were reported to be among the devices used in the procedures, baylis medical company has decided to submit this report.Separate mdrs have been submitted for the nrg transseptal needle and protrack pigtail wire with mdr numbers 9710452-2022-00003 and 9710452-2022-00004, respectively.[1] quinn, r.W., vesely, m.R., dawood, m., benitez, m., holmes, s.D., & gammie, j.S.(2021).Transseptal puncture learning curve for transcatheter edge-to-edge mitral valve repair.Innovations, 1556984521992403.

Manufacturer Narrative

There is no evidence to suggest that the baylis medical devices caused or contributed to the reported complications.However, as baylis medical devices were reported to be among the devices used in the procedures, baylis medical company has decided to submit this report.There is no suspected device failure.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 13251754
• MDR Text Key: 283765516
• Report Number: 9710452-2022-00002
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death; Required Intervention