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

Model Number TELE6F

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an attempt was made to use a 6f telescope guide extension catheter to treat a severely calcified and moderately tortuous lesion exhibiting 50-60% stenosis located in the mid right coronary artery (rca).The device was removed from the packaging as per ifu.The device was inspected and prepped per ifu with no issues noted.Resistance was not encountered when advancing the device.Excessive force was not used during insertion/delivery.It was reported that the telescope gec was used for support to place one stent in the mid rca.Residual proximal rca stenosis was still noted and needed an additional rca overlap stent in the proximal lesion.While placing the second stent the telescope was pulled back and it was stated that the tip detached from the catheter and then traveled down the vessel.An attempt was made to remove the device with a snare, however this attempt was unsuccessful.Multiple attempts were made to retrieve the device.Eventually the device migrated further down the vessel.A coronary dissection occurred.The full rca was then stented to keep telescope tip from moving any further.The entire vessel had to be stented up to the proximal rca due to the dissection plane.The patient remains unstable in the ccu.

Manufacturer Narrative

Additional information: the lesion was pre-dilated.Both stents used during the procedure were none medtronic devices resistance was not encountered during withdrawal of the device and excessive force was not used.It was later reported that the patient was discharged to a rehab facility for further care.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: a total of six images were returned for analysis.A deployed stent was identified in the mid-rca.From the images received the detached tip can be identified migrating in to the distal rca.Two potential dissections were identified, one in the mid-distal rca and another in the distal rca, however neither can be confirmed from the still images received.Annex d, annex g codes added.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

Correction h6 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: during a procedure an attempt was made to use a 6f telescope guide extension catheter (gec) to treat a severely calcified and moderately tortuous lesion exhibiting 50-60% stenosis located in the mid/distal right coronary artery (rca) just proximal to the crux.It was noted that this procedure was performed at a hospital without surgical back-up and no rotational atherectomy available.Resistance was encountered during inch worming the telescope and embedding the catheter into the calcified lesion.Backup was an issue and the procedure was changed from radial to femoral approach.Standard pci equipment such as balloons would not advance and a telescope was used for backup support.The telescope was inch wormed to the distal rca approximately 2 cm proximal to the crux.It was noted that it was hard to push the catheter and there was tremendous forward pressure to advance the telescope but there was no tactile feedback on the catheter.While placing the second non-medtronic stent the telescope was pulled back and it was stated that the tip detached from the catheter and then traveled down the distal vessel.Attempts were made to push the telescope out by advancing the balloon and inflating a balloon distally trying to retract proximally.Multiple attempts were made to retrieve the device, including using a distally inflated balloon, however this was not successful.A wire was placed on the outside of the fractured tip, and the tip was exteriorized by inflating a stent in the distal rca.The patient made an uneventful recovery.It was stated that this case was at the far end of the scope for complexity and the physician feels that the telescope performed well compared to other gec and it is believed that this complication is due to the complexity of the lesion.The physician felt that the excess torsion and embedding the telescope into the calcified lesion caused it to fixate and fracture.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: 12116457
• MDR Text Key: 260046485
• Report Number: 9612164-2021-02604
• 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,Followup,Followup,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0010619727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male