MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN-TRANSSEPTAL NEEDLE KIT

Model Number	00884450263181
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Cardiac Tamponade (2226); Decreased Respiratory Rate (2485); Low Cardiac Output (2501); Blood Loss (2597)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a difficult transseptal puncture to complete an ablation procedure, a pericardial effusion occurred.The physician had acquired access through the fossa ovalis and into the left atrium with a coronary sinus catheter attempting to effectively map the left atrium for this patient.After a few seconds of use, the catheter would not deflect as intended.The catheter was replaced, and the procedure was continued.After mapping the left atrium, the patient became hypotensive.Ultrasound confirmed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient and the procedure was discontinued.The physician alleged the effusion occurred during the transseptal puncture procedure.The physician attempted several times to acquire access with the needle which resulted in the effusion.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Should the suspect medical device be returned at a later date, the investigation will be re-opened.

• Brand Name: HEARTSPAN-TRANSSEPTAL NEEDLE KIT
• Common Device Name: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 9973603
• Report Number: 2529252-2020-00006
• Device Sequence Number: 2897763
• Product Code: DYB
• UDI-Device Identifier: 00884450263181
• UDI-Public: 00884450263181
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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 Model Number: 00884450263181
• Device Catalogue Number: FND-020-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOT VASCULAR - SWARTZ, SL0
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention