MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN® STEERABLE SHEATH; INTRODUCER, CATHETER

Catalog Number	HST-085-10/C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returning 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 reopened.
Event or Problem Description
The account alleges that during a structural heart intervention [laa] procedure, vessel trauma occurred.The account believes this was due to use error.The operator had applied too much pressure during the puncture [tenting] ultimately breaking through the septal wall with the access sheath resulting in damage to the atrial roof.No additional patient consequence to report.

• Brand Name: HEARTSPAN® STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 21304805
• Report Number: 3010665433-2025-00005
• Device Sequence Number: 8169628
• Product Code: DYB
• UDI-Device Identifier: 00884450693704
• UDI-Public: 884450693704
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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: HST-085-10/C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown