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	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the transseptal needle, ep003994s with lot number 211698420, 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 transseptal puncture the needle scratched the inner lumen of the competitor sheath.No particles were loosened but resistance was noted.No patient complications have been reported as a result of this event.

• 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: 9857957
• Report Number: 9612164-2020-01241
• Device Sequence Number: 2611753
• 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: Other
• 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: 08/17/2018
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 211698420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2016
• 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