MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. BRK; TROCAR

Model Number XS SERIES

Device Problems Mechanical Problem (1384); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Event Description

Physician placed 98 cm brk xs needle in medium curl agilis sheath to attempt to puncture transseptal through the heart.Physician did not cross the septum and took the needle out of the sheath, and found that it did not have the correct curve.Brk xs transseptal needle with altered curve on end; exchanged for new needle.No harm to patient."needle returned to company for evaluation.".

• Brand Name: BRK
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8018608
• MDR Text Key: 125471629
• Report Number: 8018608
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: XS SERIES
• Device Catalogue Number: G408540
• Device Lot Number: 100145626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA