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

Model Number G407211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Great Vessel Perforation (2152)

Event Date 05/27/2021

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 257267903
• Report Number: 3008452825-2021-00329
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: 05414734205153
• Combination Product (y/n): N
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS SHEATH
• Patient Outcome(s): Other