MAUDE Adverse Event Report: MEDTRONIC IRELAND TELESCOPE GUIDE EXTENSION CATHETER; CATHETER, PERCUTANEOUS

Model Number	TELE6F
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: annex d code.Corrections: annex c code.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
Product analysis: one 6fr telescope was received for analysis.A tip detachment was evident with coils exposed and stretched.The detached tip, including distal marker band, did not return.The od of the undamaged section of the lumen was within specification.It was not possible to verify the lumen patency due to the tip detachment.No other damage evident to the remainder of the device.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.
Event or Problem Description
One telescope guide extension catheter was returned to medtronic.It was indicated that the device was defective.No patient injury reported.

• Brand Name: TELESCOPE GUIDE EXTENSION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19114075
• Report Number: 9612164-2024-01813
• Device Sequence Number: 7820177
• Product Code: DQY
• UDI-Device Identifier: 00763000156954
• UDI-Public: 00763000156954
• Combination Product (Y/N): N
• PMA/510(K) Number: K183353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 01/09/2025
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0011583020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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