MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH NEEDLE; TROCAR

Model Number EP003994S

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior to a radiofrequency (rf) procedure, while inspecting the needle, the physician touched the tip and it broke off.The product was replaced with a competitor product.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: the device was returned and analyzed.Visual inspection of the needle showed that the distal end of the needle was kinked/bent indicating damage during use.In conclusion, the product had performance issues due to operational context.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7461253
• MDR Text Key: 106703144
• Report Number: 9612164-2018-00905
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 06/07/2018

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: 03/01/2019
• 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: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• 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
• Patient Age: 37 YR
• Patient Weight: 83