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

Model Number EP003994S

Device Problem Break (1069)

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

Event Date 07/17/2014

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the transseptal needle, ep003994s with lot number 208171403, was returned and analyzed.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.

Event Description

It was reported that during preparation of the sheath and the needle outside the patient, the user noticed that plastic material was scratched from the inside of the sheath by the needle (with dilator inserted).No patient complications have been reported as a result of this event.

• 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: 9857940
• MDR Text Key: 188900902
• Report Number: 9612164-2020-01238
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2016
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 208171403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2014
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 03/19/2020
• Date Device Manufactured: 03/25/2014
• 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