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

Model Number TELE6F

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/21/2023

Event Type  Injury  

Event Description

An attempt was made to use one 6f telescope guide extension catheter (gec) in a lesion in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.The device was prepped per ifu with no issues noted.Resistance was not encountered when advancing the device.Excessive force was used during the insertion/delivery.It was reported that the tip of the telescope was damaged and detached.It was detailed that after a non-medtronic stent was deployed a final check was performed on the stent deployment, and an intravascular ultrasound (ivus) catheter was advanced through the telescope.During removal of the ivus and telescope device resistance was encountered.Force was used and the system was removed.It was then noted that the tip of the telescope was damaged and had detached.The detached tip was in the patient's artery with the ivus.Due to the patient's condition, it was decided to abort the percutaneous coronary intervention (pci) and send the patient for coronary artery bypass graft surgery (cabg) for grafting.The detached tip remains in the patient.The patient has some complication post grafting surgery.The patient is alive with no further injury.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Additional information: the non-medtronic (mdt) stent also remained in the patient.The telescope had been used successfully in the deployment of the non-mdt stent prior to the resistance experienced with the ivus.Attempts were made prior to the cabg procedure to retrieve the tip of the telescope device.The cabg procedure was performed as the treated artery totally occluded.The detached tip was not removed during the cabg procedure.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the lesion was pre-dilated.It was suggested that there was tear on the ivus.No snare was used to remove the detached tip, a different technique was used to retrieve it.Image analysis:the first image was of the shelf carton.The lot number and device details match the reported lot number.Handwritten text in black ink was written on the shelf carton with details of the procedure.The second image was of the distal section of the gec with a non-medtronic device protruding from the tip of the gec.The gec shelf carton was in the background.Deformation was evident to the distal tip however it was not possible to confirm tip detachment from the image provided.Product analysis: the device was received for analysis.A non-medtronic stent delivery system was loaded in the gec upon return.The tip of the non-medtronic sds and one of its stent wraps was protruding from the distal tip of the gec.That stent wrap was caught on the gec tip and the edge of the gec tip was folded in on itself.The gec tip was also bunched.The stent wrap was manipulated, and this allowed for the removal of the non-medtronic sds from the gec.The stent remained intact on the non-medtronic sds upon removal.Further analysis of the gec tip revealed that while there was deformation evident to the tip material, the edge of the tip material was present, indicating tip detachment had not occurred.The markerband was present and undamaged and the coils were not protruding through the tip material.A 0.0540" inch lumen patency ball was advanced through the lumen; however, resistance was met when passing through the damaged tip.Od measurements; entry port od 0.0684 inches; proximal bond od = 0.0676 inches; distal bond od = 0.0686 inches; distal tip od = 0.0735 inches.Specifications: max od = 0.0779 inches.The distal tip od was not within specification due to the deformation to the tip.No other damage evident to the remainder of the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the ivus used was a non-medtronic (mdt) device.During removal of the non-mdt stent and telescope device resistance was encountered.The telescope encountered issues when used with the non-mdt ivus.The telescope device did not cause deformation to the non-mdt stent.It was suggested that the cabg was not related to the pci procedure as the non mdt stent was deployed successfully.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 17661638
• MDR Text Key: 322395303
• Report Number: 9612164-2023-03961
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K183353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0011740705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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; Other
• Patient Sex: Female