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

Model Number 407200

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When puncturing the fossa ovalis, the needle broke and detached.The detached portion of the needle was removed from patient and another needle was used to continue the procedure with no consequences to the patient.

Manufacturer Narrative

One brk transseptal needle was received for evaluation.Visual inspection revealed the distal tip of the needle had been fractured and detached proximal to the distal tip.The needle tip was not returned.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured needle is consistent with forcible contact.The brk needle instructions for use states ¿do not alter this device in any way.¿.

Event Description

Additional information received confirmed the device did not break apart in the patient.It was removed as normal with no consequences to the patient.

• Brand Name: BRK¿ 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: 8623519
• MDR Text Key: 145496343
• Report Number: 3008452825-2019-00242
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• 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,Followup
• Report Date: 06/14/2019

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: 12/31/2021
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 6818916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 05/19/2019; 06/10/2019
• Supplement Dates FDA Received: 05/24/2019; 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other