MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. TRANSSEPTAL NEEDLE KIT AND STYLET; HEARTSPAN NEEDLE

Catalog Number	FND-019-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.
Event or Problem Description
The account alleges that during an atrial fibrillation radio frequency ablation procedure, a pericardial effusion occurred.The patient remained asymptomatic, however, an ice catheter revealed a pericardial effusion.A pericardiocentesis was performed and the pericardium was drained of fluid.Patient remained stable and was monitored overnight.The healthcare specialist believes that the adverse health consequences were unrelated to product performance.

• Brand Name: TRANSSEPTAL NEEDLE KIT AND STYLET
• Common Device Name: HEARTSPAN NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley pkwy; malvern PA 19355
• MDR Report Key: 11373604
• Report Number: 2032338-2021-00002
• Device Sequence Number: 3742789
• Product Code: DRC
• UDI-Device Identifier: 00884450169704
• UDI-Public: 884450169704
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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 Catalogue Number: FND-019-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 79