MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH¿ NEEDLE; TROCAR

Model Number	EP003994S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the transseptal needle, ep003994s with lot number 212632798, was returned and analyzed.There were no anomalies found.The reported skiving issue was not confirmed; however, 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.
Event or Problem Description
It was reported that during a radiofrequency (rf) ablation procedure, the transseptal needle was scratching the inside of the dilator and could not be advanced out of the dilator.The needle and sheath were replaced.No patient complications have been reported as a result of this event.The case was completed and no debris or particles were noticed.

• Brand Name: BROCKENBROUGH¿ NEEDLE
• Common Device Name: TROCAR
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9857984
• Report Number: 9612164-2020-01242
• Device Sequence Number: 2611754
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 212632798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1