MAUDE Adverse Event Report: CARDIOFOCUS HEARTLIGHT; HEARTLIGHT DEFLECTABLE SHEATH

Model Number	18-3356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device deficiency reported.Evaluation of returned device found no deficiency.It cannot be determined from the information provided if an air embolism occurred and if so, what device or devices caused or contributed to the embolism.However, treatment was provided to the patient.The sheath cannot be conclusively excluded as a possible cause for this event.Air embolism is a known potential adverse event for catheter ablation procedures disclosed in product labeling.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, st segment elevation was noted when the ablation catheter was inserted.Coronary angiography did not confirm an air embolism but the possibility of coronary spasms was suggested.Medication was administered and the st segment elevation was no longer observed.Echocardiography found no abnormality in the motion of the atrial wall, suggesting there was no damage to the cardiac muscle.Review of the procedural data confirmed the st segment elevation occurred prior to the introduction of the ablation catheter.The patient exhibited no post-procedural effects from the event.In addition to the ablation sheath, three different catheters from other manufacturers were used to treat this patient.Two different diagnostic catheters were used, with the catheter exchanges occurring before the st segment elevation occurred.It was also reported that it took nearly an hour to introduce a third catheter into the coronary sinus, again prior to the event.However, the treating physician could not conclusively determine the cause of the st segment elevation.Because the sheath cannot be ruled out as a cause, this mdr is being submitted.

• Brand Name: HEARTLIGHT
• Common Device Name: HEARTLIGHT DEFLECTABLE SHEATH
• Manufacturer (Section D): CARDIOFOCUS; 500 nickerson rd.; suite 500-200; marlboro MA 01752
• MDR Report Key: 10587984
• Report Number: 1225698-2020-00028
• Device Sequence Number: 11419954
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 03/31/2021
• Device Model Number: 18-3356
• Device Catalogue Number: 18-3356
• Device Lot Number: Q1486376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• 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
• Patient Age: 75 YR