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 Code	Insufficient Information (4580)
Date of Event	09/18/2024
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
An attempt was made to use a telescope guide extension catheter to treat a severely tortuous, severely calcified lesion in the mid circumflex (cx) artery.The patient was noted to have very bad anatomy.The device was inspected with no issues noted.The 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 that device detachment occurred during delivery to the lesion.Multiple balloons and shockwave were used to try and retrieve the detached portion.A lot of push force had to be used to get the various balloons down.Eventually, it was felt give and it was possible to bring back in the guide and retrieve all the pieces.The device was taken out along with the balloon slightly inflated which acted as a back stop.The guide was cut outside of the body to verify nothing was left in the body.All the detached pieces were removed.The lesion was ultimately stented with no patient injury.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: the lesion was very difficult, highly calcified and surgery turn down.The lesion was pre-dilated.The device detached near of the ramp.Non-medtronic balloons were used to retrieve the detached portion.Resistance was noted during withdrawal of the device, and excessive force was used.The lesion was ultimately stented with two onyx frontier stents with no issues.The patient is described as perfect.Product analysis: the device was returned for analysis.Analysis confirmed a kink and detachment of the push member.Detachment point was at the push member/spade marker band weld.The push member was pulled away from the on-ramp.Initial inspection noted the lumen was detached and part of the lumen had not returned, however further inspection confirmed the lumen was cut.No other damage evident to the remainder of the device.Confirming removal difficulties based on the event description and device condition.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: 20265694
• Report Number: 9612164-2024-04303
• Device Sequence Number: 15528423
• Product Code: DQY
• UDI-Device Identifier: 00763000156954
• UDI-Public: 00763000156954
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 10/17/2024

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 Expiration Date: 06/28/2026
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0012336668
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown