MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NRG RF TRANSSEPTAL KIT; CATHETER, SEPTOSTOMY

Device Problems Display or Visual Feedback Problem (1184); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Diaphoresis (2452); Pericardial Effusion (3271)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure, a pericardial effusion and cardiac tamponade occurred post procedure.After obtaining right femoral vein access, an nrg rf transseptal kit (nrg needle and troflex sheath) was inserted.There were multiple attempts of dropping onto the fossa and transseptal puncture was performed however while crossing with stiff wire, the right superior pulmonary vein (rspv) access was lost.The physician then performed another transseptal puncture using versacross connect kit (pigtail rf wire and single curve sheath/dilator) with no complications.The sheath was advanced into the left atrial appendage (laa) and the dilator was removed.Act result was 230 and an additional 2000 units of heparin given.Watchman device was inserted with one recapture performed, met the pass criteria and was released.All devices were removed from the body.There was no effusion noted at this point.After one hour while the patient being in recovery, patient became hypotensive and diaphoretic.It was discovered that the patient had a pericardial effusion with cardiac tamponade.The patient was brought back to the lab where the physician performed a pericardiocentesis.675ml of blood was removed from the patient before the patient became stable.The patient was admitted to hospital beyond standard of care and expected to be fully recovered.The device is not expected to be returned for analysis.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure, a pericardial effusion and cardiac tamponade occurred post procedure.After obtaining right femoral vein access, an nrg needle was inserted through troflex sheath.There were multiple attempts of dropping onto the fossa and transseptal puncture was performed however while crossing with stiff wire, the right superior pulmonary vein (rspv) access was lost.The physician then performed another transseptal puncture using versacross connect kit (pigtail rf wire and single curve sheath and connect dilator) with no complications.The sheath was advanced into the left atrial appendage (laa) and the dilator was removed.Act result was 230 and an additional 2000 units of heparin given.Watchman device was inserted with one recapture performed, met the pass criteria and was released.All devices were removed from the body.There was no effusion noted at this point.After one hour while the patient being in recovery, patient became hypotensive and diaphoretic.It was discovered that the patient had a pericardial effusion with cardiac tamponade.The patient was brought back to the lab where the physician performed a pericardiocentesis.675ml of blood was removed from the patient before the patient became stable.The patient was admitted to hospital beyond standard of care and expected to be fully recovered.The device is not expected to be returned for analysis.It was further clarified it is believed that the effusion was from multiple drop downs from the superior vena cava onto the fossa, the physician tried multiple times and attempted to cross with poor visualization the first time with nrg.He lost access to the left atrium and when he restuck the septum he used connect and was much easier.The comment on the stiff was probably referring to a protract wire for sheath exchange and that was when he lost access.

Manufacturer Narrative

Correction to the complaint summary and device codes, mdr in block(s) fb5, f10 and h6.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: NRG RF TRANSSEPTAL KIT
• Type of Device: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17568577
• MDR Text Key: 321406050
• Report Number: 2124215-2023-43951
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 79 YR
• Patient Race: White