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

Model Number EP003994S

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical productus: product id: ep003994s, lot# 215418987; product id: ep003994s, lot# 215418987.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a radiofrequency procedure, while advancing the needle through a sheath, the needle scratched inside of the sheath.Part of the sheath came off as a result of this issue.This occurred three times.The case outcome is unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the needle, ep003994s with lot number 215418987, was returned and analyzed.Visual inspection of the needle showed that there was no kink on the shaft.There was no sheath returned for investigation.In conclusion, the reported skiving issue could not be confirmed through testing.The returned needle passed the returned product inspection.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Incoming information indicated that the needle was replaced with a competitor product and the procedure was able to be completed.

Manufacturer Narrative

Product event summary: the transseptal needle, (b)(4) with lot number 215418987, was returned and analyzed.Visual inspection of the needle showed that there was no kink on the shaft.There was no sheath returned for investigation.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.

• 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: 7986522
• MDR Text Key: 124544876
• Report Number: 9612164-2018-02847
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup,Followup,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 215418987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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