MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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 01/06/2017

Event Type  malfunction  

Event Description

It was reported that during preparation for a radiofrequency procedure, the brockenbrough needle was placed into the sheath.When the needle came out of the dilator, the physician observed debris coming out of the dilator.The needle was again inserted into the dilator and aspirated debris out of the dilator.The physician mentioned that this has happened with other brands, but has not observed that much debris with other brands.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary: the needle was returned and analyzed.Visual inspection of the needle showed that the device was intact with no apparent issues.The reported debris issue was not confirmed through testing.Also, data files were received and analyzed.The files showed that at least nine injections were performed without any issues.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: 211168852, was returned and analyzed.Visual inspection of the needle showed that the device was intact with no apparent issues.The reported debris issue was not confirmed through testing.Also, data files were received and analyzed.The files showed that at least nine injections were performed without any issues.However, it is plausible that sieving 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 PUERTO RICO OPERATIONS CO.; road 149, km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 149, km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6466063
• MDR Text Key: 72214816
• Report Number: 2649622-2017-02627
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2018
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 211168852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2016
• 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: 65 YR