MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

No product was returned for investigation. a review of the device history record was not possible since the batch number is unavailable.Based on the information provided to abbott, the reported perforation and extravasation could not be confirmed.

Event Description

The following was published in cardiovasc intervent radiol in an article titled ¿approach, technical success, complications, and stent patency of sharp recanalization for the treatment of chronic venous occlusive disease: experience in 123 patients" by mcdevitt, j, srinivasa, r, gemmete, j, et al., 20 november 2018.".In 1 (0.8%) procedure, there was perforation of the right brachiocephalic vein with resulting right hemothorax during a successful recanalization of an occluded right jugular vein with a transseptal needle and loop snare, managed with placement of a 10 mm 9 4 cm fluency.Covered stent (bard, murray hill, nj) and uncomplicated placement of chest tube.There were 7/123 (5.7%) minor adverse events, which included 4 (3.3%) cases of self-limited retroperitoneal extravasation and 1 (0.8%) case each of self-contained extravasation into the mediastinum, pelvis, and left upper arm" (doi: https://doi.Org/10.1007/s00270-018-2090-1).

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 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 (AFD); 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: 8487375
• MDR Text Key: 141056046
• Report Number: 3008452825-2019-00154
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other