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 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a radiofrequency (rf) procedure, the needle was unable to be removed from the sheath.It was noted that the dilator was not functioning properly due to plastic pieces blocking the dilator.A second attempt was made with a new sheath without resolve.The sheath was replaced with a competitor product.The case was completed with rf.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the brockenbrough needle, ep003994s with lot number 216980246, was returned and analyzed.External visual inspection of the needle was performed and there was no issue identified.In conclusion, the reported skiving issue was not confirmed through the product analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the transseptal needle, ep003994s with lot number 216980246, was returned and analyzed.External visual inspection of the needle was performed and there was no issue identified.The reported skiving issue could not be confirmed through testing; 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: 8683134
• MDR Text Key: 147484152
• Report Number: 9612164-2019-02257
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 216980246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 07/15/2019; 02/27/2020
• Supplement Dates FDA Received: 08/05/2019; 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• 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 Weight: 72