MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING CARDIAGUIDE¿ BRAIDED TRANSSEPTAL SHEATH KIT; INTRODUCER, CATHETER

Catalog Number	FCL-201-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not 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.A good faith effort of 3 or more attempts to collect additional information regarding this event has been completed in a timely manner.No additional information about this event or medical device use has been provided.Should the device or additional information be provided or should the device return at a later date, the investigation will be re-opened and evaluated.
Event or Problem Description
The account alleges that during an ablation procedure, the patient developed cardiac tamponade after the transseptal puncture perforated and the patient's pericardium.The patient became hemodynamically unstable and needed an emergent pericardiocentesis.During the acute pericardiocentesis access attempt, the patient's liver was hit, and the patient started bleeding internally.The patient was then stabilized and transferred to another hospital for surgical intervention where the patient expired.The device is not returning for investigation.Attempts to collect additional information regarding this event has been completed in a timely manner.No additional information about this event or medical device use has been provided.

• Brand Name: CARDIAGUIDE¿ BRAIDED TRANSSEPTAL SHEATH KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15380206
• Report Number: 3010665433-2022-00099
• Device Sequence Number: 5810166
• Product Code: DYB
• UDI-Device Identifier: 00884450407448
• UDI-Public: 884450407448
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K132720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: FCL-201-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE; TRANSEPTAL NEEDLE
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening
• Patient Sex: Unknown