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	Great Vessel Perforation (2152)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information from the field states ¿it was noted that the punctured aorta was due to the incorrect analysis of the x-ray by the physician¿ based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer report number: 3008452825-2021-00328.During a paroxysmal atrial fibrillation (af) procedure, the aorta was punctured.During review of the x-ray, the aorta became punctured by the needle and the sheath.The patient remained in stable condition, but the procedure was cancelled for the safety of the patient.It was noted that the punctured aorta was due to the incorrect analysis of the x-ray by the physician.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
One brk transseptal needle was received for evaluation.No functional anomalies were noted when the brk needle/stylet assembly was advanced through the returned 8.5f agilis dilator/sheath assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event of "the aorta was punctured" remains unknown.

• 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
• MDR Report Key: 12024364
• Report Number: 3008452825-2021-00329
• Device Sequence Number: 4543280
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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 Expiration Date: 06/30/2023
• Device Model Number: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 7598250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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: AGILIS SHEATH
• Outcome Attributed to Adverse Event: Other