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

Model Number	TELE6F
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image analysis: four still fluoroscopic images were provided for review.The images show the severe calcification in the vessel with a stent deployed in the distal vessel.The inner shaft marker bands are evident in the mid to distal vessel.The images show the detached telescope tip, initially in the distal lesion but it was moved to the proximal vessel.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 the tip of one 6f telescope guide extension catheter (gec) detached during removal.The lesion being treated was mildly tortuous, severely calcified with 80-90% stenosis in the mid right coronary artery (rca).The device was inspected prior to use with no issues noted.The device had been prepped per ifu with no issues noted.Resistance was encountered when advancing the device.The patient had a previously deployed stent in the area.A balloon was inflated over the proximal lesion to inchworm the telescope tip to the distal lesion.The telescope tip got stuck in the distal lesion and during attempts to remove the device the tip detached.A small balloon was advanced through the telescope tip, inflated, and an attempt was made to extract the tip by pulling the inflated balloon back toward the guide, but this was unsuccessful.The telescope tip could not traverse back through the proximal lesion.The patient was transferred to a qualified facility for possible surgical removal.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the lesion was not pre-dilated.The telescope tip got stuck on the calcified proximal portion of the distal lesion and during attempts to remove the device the tip detached.Resistance was noted during attempted withdrawal of the device, as the device was stuck.It is likely that excessive force was used in attempting to remove the device as initially the device could not be removed, and enough force was used to detach the tip.The patient was transferred to a qualified facility for possible surgical removal.However, the telescope tip had migrated to the distal portion of the posterior descending artery (pda) and attempts to retrieve it were not made.The detached tip was not removed.The lesion was treated successfully, and the patient did well.Device lot number provided.Patient information provided.Event date updated.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: no deformation was evident to the on-ramp or entry port.A detachment was evident to the distal tip.The inner lumen of the telescope was verified using a lumen 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.
Additional Manufacturer Narrative
Additional information: annex d code.Correction: 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.

• 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: 21772050
• Report Number: 9612164-2025-01735
• Device Sequence Number: 13176254
• Product Code: DQY
• UDI-Device Identifier: 00763000156954
• UDI-Public: (01)00763000156954(17)261219(10)0012596945(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0012596945
• 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: 03/09/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/12/2025; 07/11/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/26/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic