MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number 407200

Device Problem Difficult to Insert (1316)

Patient Problem Vascular Dissection (3160)

Event Date 01/23/2020

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: 3005334138-2020-00060.During the procedure, a dissection of the superior vena cava (svc) occurred.While preparing the introducer prior to patient insertion, a small obstruction was observed at the tip of the sheath while flushing.The brk needle was inserted through the sheath to clear the blockage but resistance was noted.Despite the obstruction and insertion difficulty, the introducer set and brk were inserted into the patient.Once positioned at the svc, the brk needle was attempted to be inserted through the introducer however resistance was felt.The needle was pushed through the introducer and dissected the svc.The introducer and needle were removed and ice confirmed a small bleed.The bleed resolved without any intervention.After the bleeding resolved the procedure was completed successfully.

Manufacturer Narrative

No visual anomalies were noted on the returned brk needle/stylet assembly.The brk needle/stylet assembly was advanced through an 8.5f sl1 dilator/sheath assembly from current inventory; no resistance or functional anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported insertion difficult and dissection remains unknown.Per the ifu, intimal dissection is a known risk during the use of this device.

• Brand Name: BRK¿ TRANSSEPTAL NEEDLE, 71 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: 9714841
• MDR Text Key: 183003163
• Report Number: 3008452825-2020-00094
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (y/n): N
• PMA/PMN Number: K072278
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 7096452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Patient Outcome(s): Other