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

Model Number 407201

Device Problem Flaked (1246)

Patient Problem Cardiac Perforation (2513)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

The reported event of skiving and insertion difficulty could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturing ref:3005334138-2019-00335.During a paroxysmal atrial fibrillation cryoablation procedure, a pericardial effusion occurred, which led to the procedure being cancelled.There was resistance when attempting to flush the brk-1 needle after gaining transseptal access to the left atrium.After withdrawing the sl1 sheath, it was noted that the needle had white plastic material at the tip, which was believed to be the white plastic scraped from the inside of the sheath.While setting up the cryoballoon, it was noted on ice that there was a minor pericardial effusion.A pericardiocentesis was performed to treat the pericardial effusion.The procedure was continued but eventually aborted due to concerns about the effusion.

• Brand Name: BRK-1¿ 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: 8752693
• MDR Text Key: 149776332
• Report Number: 3008452825-2019-00307
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 6904404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Weight: 113