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

Model Number	EP003994S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radiofrequency (rf) ablation procedure, the needle along with the needle wire was inserted through the sheath to ensure proper function.The needle was retracted and a scratch on the inner tube of the sheath was observed.It was noted that the needle scratched the sheath.The sheath was replaced and the needle was cleaned.When preparing the new sheath and needle, the needle (with the needle wire) was inserted into the sheath dilator to check proper function.When the needle got retracted, it was observed that the needle had scratched the inner tube of the sheath.Additionally, there was visible inner deformation in the distal tip of the dilator.The sheath was replaced which resolved the issue.The needle was cleaned to remove the plastic. when attempting the transseptal puncture, the needle was not able to be advanced.It was noted that something was blocking it.The needle and the sheath were retracted and visual inspection indicated that the tip of the dilator was deformed and the tip of the needle had plastic residue on it.The outcome of this case is unknown.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id 990061-070 lot# dp-19055 serial# implanted: n/a explanted: n/a product id ep003994s lot# 226239854: n/a explanted: n/a product id 990061-070 lot# dp-18999 serial# implanted: n/a explanted: n/a 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.
Additional Manufacturer Narrative
**udi related data quality updates only** d4 (provide complete udi).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Corrected: d4.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BROCKENBROUGH¿ NEEDLE
• Common Device Name: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18249461
• Report Number: 9617601-2023-00241
• Device Sequence Number: 6600801
• Product Code: DRC
• UDI-Device Identifier: 00613994663146
• UDI-Public: (01)00613994663146(17)250404(1
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2025
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Device Lot Number: 226239855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: Not provided; 08/26/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 07/24/2024; 08/26/2024
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown