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); Positioning Problem (3009)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
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 involving one 6f telescope extension guide catheter (gec), positioning difficulties were en countered and the tip of the telescope detached.The lesion being treated was moderately tortuous, moderately-severely calcified, eccentric focal lesion with 90% stenosis located in the proximal right coronary artery (rca).The telescope gec was inspected prior to use with no issues noted.The telescope gec was prepped per ifu with no issues noted.Resistance was encountered when advancing the device but excessive force was not used during insertion/delivery.One compliant balloon ruptured at the lesion but was released using a non-complaint balloon with a local dissection noted.Balloon dilation was performed outside the telescope gec, however the telescope gec would not pass beyond this point in artery but with the guide gave adequate support to place the distal stent.Upon placement of the second stent that extended proximal to the telescope gec, the tip came off the telescope during removal with only mild extraction pressure with the guide for proximal stent positioning.The patient underwent an urgent coronary artery bypass graft (cabg).No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: upon device return, it was observed that a portion of the tip material had detached, exposing the inner coil.The material at the detachment site appeared jagged and uneven.The od of the undamaged lumen was within specification.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: one 2.5 x 15mm non-medtronic compliant balloon ruptured in the proximal mildly tortuous calcified segment of the lesion but was released using a 2.5 x 15mm non-medtronic non-compliant balloon.The non medtronic non-compliant balloon did not rupture and dilated the lesion appropriately however it cause a localized dissection.Balloon dilation was performed outside the telescope gec and as the balloon deflated the telescope gec was advanced over the balloon in a standard technique to advance into the artery to be able to deliver stents distally.However the telescope gec would not pass beyond this point in artery that was dilated and no further attempt was made to advance it but with the guide gave adequate support to place the distal stent.One non-medtronic 2.25 x 38mm stent was advanced easily through the guide catheter and the telescope gec to the distal rca and delivered at standard high-pressure without difficulty with the balloon being withdrawn out of the body without problem.A second 3.0 x 38mm non-medtronic stent was placed in a planned overlapping fashion in the proximal rca.An attempt was made to withdraw the telescope gec over the stent into the guide in the final efforts to place the stent, but difficulties were encountered removing the telescope.The guide was repositioned, the tip was moved up and down, the telescope was wiggled and gently pulled back on both as a unit at which time the telescope gec jumped back in to the guide and the tip came loose and remained in the artery.Excessive force was not used during removal.The detached tip was not able to be removed from the rca.It was believed that the tip was likely attached to a heavily calcified coronary spicule in the artery with no danger of embolization.The patient was discharged approximately six days later without incident.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.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: 22201560
• Report Number: 9612164-2025-02902
• Device Sequence Number: 7723469
• Product Code: DQY
• UDI-Device Identifier: 00763000156954
• UDI-Public: (01)00763000156954(17)270130(10)0012649062(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 09/04/2025

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: 0012649062
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/22/2025; 09/03/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/10/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 77 KG