MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	G407211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During the ablation procedure, a cardiac tamponade occurred, and a drainage was performed.The transseptal puncture was performed, and it was noted to be difficult as the location was fibrous due to pervious transseptal crossings.After the left atrial access was gained, it was noted that the patient's blood pressure dropped.When the ultrasound was conducted, a cardiac tamponade was observed.The ablation procedure was cancelled at this time, and a drainage was performed.No further patient complications were noted.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20256909
• Report Number: 3008452825-2024-00528
• Device Sequence Number: 20723898
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: G407211
• Device Catalogue Number: G407211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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