MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number G407209

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

Patient Problem Great Vessel Perforation (2152)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 3005334138-2019-00907.During an atrial fibrillation ablation procedure, a perforation of the aorta occurred during transseptal puncture.The puncture was too anterior and a perforation was confirmed vis fluoroscopy.The patient was transferred to cardiac surgery for repair and is in stable condition.There were not any performance issue with any abbott devices.

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.Based on the information received, the cause of the reported perforation remains unknown.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 9483579
• MDR Text Key: 173167240
• Report Number: 3008452825-2019-00641
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• 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: 02/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 7121697
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SWARTZ¿ BRAIDED INTRODUCER, SL0
• Patient Outcome(s): Required Intervention