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

Model Number	00884450169704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
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 review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that during a transseptal puncture the needle punctured the epicardium.The procedure was cancelled.

• Brand Name: HEARTSPAN TRANSSEPTAL NEEDLE
• Common Device Name: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 9857537
• Report Number: 2529252-2020-00005
• Device Sequence Number: 19499111
• Product Code: DRC
• UDI-Device Identifier: 00884450169704
• UDI-Public: 00884450169704
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: 00884450169704
• Device Catalogue Number: FND-020-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1