MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING HEARTSPAN TRANSSEPTAL NEEDLE; TRANSSEPTAL TROCAR

Catalog Number	FND-020-02/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during an a-fib ablation procedure, while performing a transseptal puncture there was difficulty visualizing through the tee probe.The physician mentioned that the left and right atrium where differently orientated than in a normal anatomy and the septum was turned to a more posterior position.The first transseptal puncture was successfully completed with the preface sheath and heartspan needle.Normal pressures noted from within the left atrium.Then a secondary puncture for a second sheath, only a few millimeters more posterior was attempted.It was not possible to see the tip of the needle on echo [tenting] during transseptal puncture.It was noted that post-second heartspan needle/sheath puncture, that no blood was returning, only transparent fluid.Very low pressures were noted within the patient.After guide wire insertion, it was clear that the sheath was inadvertently placed within the epicardial space.This was confirmed by echo.Patient remained stable, no hemodynamic changes to report.Pericardial effusion was noted and approximately 60ml's of fluid was retracted from the pericardial space.The patient had 2500 units of heparin before puncture.Procedure was on hold for 30 minutes.After retracting the sheath, the physician administered protamine to reverse and neutralize the anticoagulant effects of heparin.The wire was still in place.Still no hemodynamic changes.Procedure was on hold for an additional 30 minutes.Patents pressures were still stable.The patient was transferred to recovery unit.The account concludes that because of transseptal puncture being so posterior, it may have caused a pericardial effusion.Sheath was placed in epicardium of right atrium.Patient tolerated the event well and remained stable throughout the procedure.No additional medications administered.The patient was admitted to the hospital for overnight observation.
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.

• Brand Name: HEARTSPAN TRANSSEPTAL NEEDLE
• Common Device Name: TRANSSEPTAL TROCAR
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• MDR Report Key: 11667583
• Report Number: 3010665433-2021-00021
• Device Sequence Number: 3160866
• Product Code: DRC
• UDI-Device Identifier: 00884450286449
• UDI-Public: 884450286449
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 09/16/2023
• Device Catalogue Number: FND-020-02/A
• Device Lot Number: E1913604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: HEARTSPAN®.TRANSSEPTAL SHEATH
• Outcome Attributed to Adverse Event: Required Intervention