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

Model Number	TELE7F
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that during a procedure an attempt was made to use one telescope guide extension catheter to treat a moderately tortuous, non-calcified lesion located in the mid saphenous vein graft (svg) and a device detachment occurred.It was stated that during advancement through the guide the telescope broke.The device was removed from the guide catheter as it was still connected.The device was removed from packaging and prepped per ifu with no issues noted.The device was inspected with no issues noted.Resistance was not encountered when advancing the device and excessive force was not used during insertion/delivery.The patient is alive withno injury.
Additional Manufacturer Narrative
Additional information: the device detachment occurred near the on ramp on the shaft.The tip did not detach.No resistance was noted during withdrawal of the device.Product analysis: the device returned for evaluation.Deformation and peeling were evident to the on-ramp.No deformation was evident to the entry port.No deformation was evident to the distal tip.The inner lumen of the telescope was verified using a patency ball.No other deformation 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.

• 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: 20757474
• Report Number: 9612164-2024-05498
• Device Sequence Number: 21148227
• Product Code: DQY
• UDI-Device Identifier: 00763000156978
• UDI-Public: 00763000156978
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Followup
• Report Date (Section B): 12/18/2024

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: 12/01/2024
• Device Model Number: TELE7F
• Device Catalogue Number: TELE7F
• Device Lot Number: 0011533157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 11/30/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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