MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BROCKENBROUGH¿ NEEDLE; TROCAR

Model Number EP003994S

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported that during a transeptal procedure, the needle could not advance through the sheath.The sheath was replaced, but the issue persisted.Saline was attempted to be flushed through the sheath, but remained within the sheath, unable to advance through the tip.The sheath and needle were replaced which resolved the issue.The case was completed. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id 990061-070 product type sheath; product id 990061-070 product type sheath product event summary: the ep003994s transseptal needle with lot number (b)(6).Was returned and analyzed.The transseptal needle was visually inspected and functionally tested and no visible blood was found on the needle.The transseptal needle was intact with no apparent issues, no kink or bend was noted along the needle, however the needle was unable to enter into the returned dilator sheath.Upon evaluation of the returned sheath dilators, it was found that there was skived material and skive marks inside of both sheath dilators when checked with a borescope.In conclusion, the product analysis of the transseptal needle confirmed the transseptal compatibility issue.The transseptal needle passed the returned product inspection as per specification.However, when the sheath dilators were analyzed, it was found that there was skived material and skive marks inside of both dilators.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18221259
• MDR Text Key: 329163435
• Report Number: 9617601-2023-00238
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: 00613994663146
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2023

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 Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 225304499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• 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
• Treatment: SEE H10....