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

Model Number G407209

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  Injury  

Event Description

Related manufacturer reference number: 3005334138-2018-00410, 3005334138-2018-00411.During an ablation procedure the transseptal needle would not pass through the introducer.The sheath was replaced and again the needle would not insert through the introducer, even after reshaping the needle.This caused a clinically significant delay in the procedure.A non-abbott sheath and transseptal needle were used to complete the case with no adverse consequences to the patient.

Manufacturer Narrative

One brk transseptal needle and stylet were received for evaluation.Two sheath/dilator assemblies were also returned.The stylet was returned kinked at multiple locations, consistent with reshaping the stylet.No functional anomalies were noted when the brk needle and a stylet from current inventory were advanced through the returned sheath/dilator assembly.The brk transseptal needle instructions for use (ifu) direct the user not to alter this device in any way.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported needle insertion difficulty is consistent with the reshaping of the stylet.The cause of the stylet kinks is consistent with damage during use.

• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8023265
• MDR Text Key: 125599130
• Report Number: 3008452825-2018-00366
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: 05414734205184
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: G407209
• Device Lot Number: 6617308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FAST-CATH INTRODUCER; FAST-CATH INTRODUCER