MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT SHEATH

Model Number	18-3356
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device expected to be returned but has not been received yet.No device deficiency was reported and it cannot be determined if there is any involvement of the deflectable sheath introducer and the air entry.Air embolism is a known potential adverse event for catheter ablation procedures disclosed in product labeling.If the device is returned and the evaluation reveals relevant information to this event, a supplemental mdr will be submitted.
Event or Problem Description
During a pulmonary vein isolation procedure to treat atrial fibrillation in a patient with sleep apnea, the physician noted the presence of air inside the right atrium on the fluoroscopic image before the ablation catheter was introduced.The deflectable sheath introducer for the ablation procedure had been introduced following a swartz sl0 sheath after the transseptal puncture was made.The presence of the air was confirmed after the guidewire and dilator had been removed from the deflectable sheath introducer.The sl0 sheath was moved into the right atrium and the air was removed.However, air entered the heart again upon the patient's deep breathing.The air was removed again and the deflectable introducer sheath was replaced and the pvi procedure completed.There was no patient adverse event.It is not known if the air entry occurred through the deflectable sheath introducer or the sl0 sheath.While no injury occurred and no device deficiency was reported, the removal of the air by the treating physician may have prevented an injury from occurring and thus this mdr will reported as a serious injury.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; marlboro MA 01752
• Manufacturer Contact: ian christianson ; 500 nickerson rd.; marlboro, MA 01752
• MDR Report Key: 16218952
• Report Number: 1225698-2023-00002
• Device Sequence Number: 12259985
• Product Code: DRA
• UDI-Device Identifier: 00868976000147
• UDI-Public: 00868976000147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

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: 10/30/2023
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: E2364265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown