MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) TRANSSEPTAL NEEDLE, BRK SERIES

Model Number 407201

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Event Description

The stylet was too thick to go through the needle.It was difficult to move through the preface sheath and four sheaths were used.The procedure was prolonged 30-40 minutes to troubleshoot.The user decided to complete the procedure with the same device.No adverse consequences for the patient.

Manufacturer Narrative

One 89cm brk needle and a 71cm stylet were returned for analysis.The stylet wire outside diameter and stylet wire length were within specifications.No functional anomalies and no resistance was noted when the returned 89cm brk needle and a stylet from current inventory were assembled and advanced through an 8.5f sl0 dilator/sheath assembly from current inventory.No functional anomalies and no resistance was noted when a 71cm brk needle from stock and the returned stylet were assembled and advanced through an 8.5f sl0 dilator/sheath assembly from current inventory.The device history record for the returned stylet was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the devices and the information provided, the cause of the reported stylet insertion difficulty and needle insertion difficulty remains unknown.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); 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: 8277555
• MDR Text Key: 134089657
• Report Number: 3008452825-2019-00020
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 6749712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/08/2019; 04/20/2019
• Supplement Dates FDA Received: 04/19/2019; 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization