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

Model Number TELE6F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis #248188278: images of device received 13-nov-2019.See all attachments tab.If information is provided in the future, a supplemental report will be issued.

Event Description

A 6f telescope guide extension catheter was being used during a procedure to treat a mildly tortuous, moderately calcified lesion ex hibiting 70% stenosis in the ostium and proximal of the left main (lm) coronary artery and left anterior descending (lad) artery.There was no damage noted to the packaging.The device was removed from the hoop as per ifu with no issues.The device was inspected with no issues.The device was prepped as per ifu with no issues.Resistance was not encountered when advancing the telescope device.Excessive force was not used during delivery.The telescope device was used to secure access to the left main artery while implanting the corevalve device.A second telescope device was used to protect the right coronary.There were no issues with the telescope device used to protect the right coronary artery.There was an old surgical non-medtronic valve and a previously deployed corevalvethat were already implanted in the past.Both of those valves had failed and another, new corevalve was intended to be implanted during this procedure.The telescope and a stent were positioned in the lm artery before deploying the corevalve.Once placed the corevalve was successfully deployed and the valve was post dilated, while the telescope was on the side of the valve.The stent did not have to be deployed because the lm ostium was not compromised by the new valve frame.It was reported that upon removal, the telescope was noted to be stuck in between two corevalves and was unable to be withdrawn.The telescope device was excessively torqued.There was no guidewire still in situ while the telescope was being torqued.It was reported that the telescope device was pulled backed using excessive force and efforts as the tip was jammed, the telescope released, but only after the distal 2mm purple tip detached off the telescope catheter.It was determined that 2mm of the telescope tip was missing by comparing the tip to a non damaged telescope on removal.The tip was left sandwiched between the corevalve frames, as it was completely stuck.The tip remains there and no intervention was performed to attempt to remove the tip section.The procedure was completed without patient injury.A 6fr launcher guide catheter and non-medtronic wire were used during the procedure.The physician assessed that the event was not a product issue but was related to the patient and the procedure.

Manufacturer Narrative

Correction: product problem only.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a 4.0 x 38 mm resolute onyx device was also used in the procedure to treat the lesion in the left main.The resolute onyx device was inspected before use with no issues noted.The lesion was not predilated.Resistance was not noted while advancing the resolute onyx device to the lesion and excessive force was not used during delivery of the resolute onyx.The telescope and 4.0 x 38mm resolute onyx stent were positioned in the lm artery before deploying the corevalve.The resolute onyx stent did not have to be deployed because the lm ostium was not compromised by the new valve frame.It was reported that upon removal, the resolute onyx was noted to be deformed and stuck in the telescope device.It was reported that stents were positioned in the arteries before deploying the corevalve in case the corevalve jailed (blocked) the ostium of the rca and lm.When the corevalve didn¿t block the arteries after deployment, the stents were removed undeployed from the lm and rca arteries.The stent from the rca was removed without issue.The lm resolute onyx stent was stuck in the telescope device.The second telescope device used to protect the right coronary artery returned for analysis.It was reported deformation occurred to this telescope device during packaging the device for return.Image review: three images received: photo 1: image shows three devices in a bio-hazard bag; two 6f telescope devices and a resolute onyx stent delivery system.Instructions written on a piece of paper in the bio-hazard bag reads; ¿do not throw away¿ and includes a signature.Photo 2: image is blurred but appears to show a stent loaded in a telescope device.Photo 3: image is blurred but shows the distal end of a telescope device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: a resolute onyx returned loaded in the telescope gec.On inspection of the devices both were deformed.The distal tip and distal markerband of the telescope gec were detached and were not returned for analysis.The coil of the telescope gec was exposed and was entangled in the deformed struts of the resolute onyx.Difficulty was encountered when attempting to separate the devices, due to the deformation of both devices the resolute onyx could not be retracted back through the lumen of the telescope gec, the proximal shaft of the resolute onyx sds was cut, and it was removed by pulling it distally through the telescope.The material at the detachment site appeared jagged.Deformation was evident to the lumen of the telescope with the device appearing narrowed approx.19 cm distal to the entry port.The inner lumen could not be verified as a 0.0540 inch patency ball could not pass through the deformed section of the lumen.A kink was evident to the push member, proximal to the on-ramp ¿ push-member material bond.Slight peeling was evident to the on-ramp ¿ push-member material bond.No other deformation was evident to the remainder of the device.Correction: three images received: an image shows three devices in a bio-hazard bag; two 6f telescope devices and a resolute onyx stent delivery system.An image is blurred but appears to show a stent loaded in a telescope device.An image is blurred but shows the distal end of a telescope device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the first telescope device was used to secure access to the left main artery, while implanting a medtronic evolut transcatheter aortic valve replacement device (tavr).The left coronary artery was a protected left main, prior to implantation.A new corevalve, medtronic evolut tavr device was intended to be implanted, during this procedure.It was stated, that the telescope lost tactile feedback after the removal of the stent and the wire.Some resistance was felt at the time of the tip fracture while removing the equipment.The tip was left sandwiched between the corevalve frames, the aorta and the evolut tavr device, as it was completely stuck.The procedure was completed without patient injury.And no further complications noted.It was stated, that the telescopes were used as the initial case plan.This was a protected left main case with transcatheter aortic valve implantation (tavi), and is a commonly used method, so it is not clear the precise reasons for the tip fracture.No other devices contributed to this event.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9383687
• MDR Text Key: 187220130
• Report Number: 9612164-2019-04928
• 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: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0009813554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1