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

Model Number	TELE6F
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the telescope was returned to medtronic (mdt) for evaluation.A non-mdt poba was entrapped in the telescope and could not be removed, and non-mdt accessory devices were also attached to the poba.The tip of the telescope was detached, and coils were exposed.The detached tip returned on the balloon of the poba.Inspection of the detached tip confirmed the markerband was present.No other damage was evident to the remainder of the device.The outer diameter of the undamaged lumen was within specification.It was not possible to perform the inner diameter lumen patency check due to the entrapment.Removal difficulties were confirmed based on the condition of the returned 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
An attempt was made to use one telescope guide extension catheter (gec) in a mildly tortuous, severely calcified lesion with 95% stenosis in the proximal left anterior descending (lad) artery.The device was inspected with no issues noted.The device was prepped per ifu with no issues noted.Resistance was not encountered when advancing the device.Excessive force was not used during insertion/delivery.The device was not excessively torqued.It was reported that resistance was experienced during removal of a 3.5 x 12mm non-medtronic intravascular lithotripsy (ivl) balloon through the lumen of the telescope.It was detailed resistance was felt when withdrawing the balloon back into the tip of the telescope post inflation.The balloon became stuck during removal.The ivl balloon and non-medtronic guidewire were entrapped in the telescope.The guidewire, telescope and ivl balloon were pulled out of the vessel and 6f launcher guide catheter together successfully.Excessive force was used during removal.Sufficient time was give to allow the balloon to fully deflate prior to attempting removal.The guidewire was examined and flushed before use with no issues noted.The ivl balloon was examined before used with no issues noted.The guidewire was successfully used with other devices prior to the difficulties occur.There was no issue with the launcher device, and the launcher device was not entrapped.The procedure was successfully completed with a new wire and stent.The patient is alive with no injury.

• 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: 19018060
• Report Number: 9612164-2024-01545
• Device Sequence Number: 11732445
• Product Code: DQY
• UDI-Device Identifier: 00763000156954
• UDI-Public: 00763000156954
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: 0011583024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/02/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown