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 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a radiofrequency (rf) procedure, skiving occurred when inserting the needle into the sheath.The sheath was replaced.The case was completed with rf.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the needle (b)(4) with lot number 215947562 was returned and analyzed.Visual inspection of the needled showed the device was intact with no apparent issues.It is possible that the tip of the needle was not fully retracted within the stylet portion contributing to the skiving of the dilator.In conclusion, the reported skiving could not be confirmed through testing.The needle passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the transseptal needle, (b)(4) with lot number 215947562, was returned and analyzed.Visual inspection of the needled showed the device was intact with no apparent issues.It is possible that the tip of the needle was not fully retracted within the stylet portion contributing to the skiving of the dilator.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: 8323571
• MDR Text Key: 135706448
• Report Number: 9612164-2019-00464
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 215947562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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