MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH NEEDLE; TROCAR

Model Number EP003994S

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an radiofrequency procedure, during the transseptal procedure, when the needle was removed from the introducer, there was material on the tip of the needle.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the transseptal needle, ep003994s was not returned.While no product was returned, an analysis of an image showed evidence of skiving.It is plausible that skiving occurred as there is a compatibility issue with the needle and a competitor sheath.The cause of the issue was not established.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BROCKENBROUGH NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7092854
• MDR Text Key: 94666004
• Report Number: 9612164-2017-01770
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2019
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 213532707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Date Device Manufactured: 07/19/2017
• 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