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

Model Number TELE6F

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Image analysis: two photos were received from the account.The first photo appears to show a detachment of the distal segment of the telescope which includes the truflex tip and distal marker band.The coil of the telescope also appears to be exposed.The second photo appears to show the 6 fr hub, and distal section of the telescope.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 Description

An attempt was made to use one 6f telescope guide extension catheter and one 3.5x38mm onyx frontier stent to treat a severely tortuous, non-calcified lesion with 95% stenosis in the mid right coronary artery (rca).The telescope device was inspected with no issues.The telescope device was prepped per ifu with no issues.Resistance was encountered when advancing the device.Excessive force was used during insertion/delivery.It was reported a tip detachment of the telescope occurred.A radial approach was used.A jr4 launcher guide catheter was deeply seated into the rca.The telescope made it to the mid vessel.When retracting the telescope after unsuccessful delivery of the 3.5x38mm onyx frontier stent, it was felt that the telescope retracted farther than expected based on the amount of distance it should have retracted.It was then noticed that the tip had separated.It was possible to retrieve the detached tip on the undelivered stent, as it remained attached to the stent.Then two 3.5x12mm onyx frontier stents were used to stent the area where initially the 3.5x38mm onyx frontier stent was attempted to be delivered.Finally, a 4.0x12mm onyx frontier stent was used to cover any possible remainder of the telescope, as there could have been a small fragment remaining in the vessel.It was stated that the telescope device worked the way it should, and that its capabilities were tested as there was a good amount of force required for delivery due to the tortuous anatomy.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: the stent was prepped.The lesion was pre-dilated with 3mm nc balloon.The stent deformed.There was no resistance noted during withdrawal of the telescope device.The telescope device was not straightened during use.There was no issues with the launcher guide, and no issues with delivery of the shorter onyx frontier stents.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.

Manufacturer Narrative

Additional information: annex d codes.Correction: annex b code.Correction - image analysis: the tip appears to be deformed.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
• Type of Device: 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: 19077208
• MDR Text Key: 339774099
• Report Number: 9612164-2024-01683
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00763000156954
• UDI-Public: 00763000156954
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0011926925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 98 KG