MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB35W06060135

Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an evercross pta balloon along with a non-medtronic 7fr sheath, a spider 0.014" 320cm guide wire and embolic protection during procedure to treat a severely calcified lesion in the proximal, mid and distal superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel was moderately tortuous.The vessel diameter and lesion length are 6mm and 150mm respectively.A non-medtronic inflation device was used for the inflation of the balloon.Inflation fluid hepsal omnipaque 60/40 was used for balloon inflation.There was no damage noted to packaging.There was no issue noted when removing device from hoop./tray.The device was prepped per ifu with no issues identified.During initial balloon inflation, balloon burst/leak/rupture occurred at 10atm.All fragments of the balloon was retrieved.The device passed through a previously deployed stent.There was resistance encountered when advancing the device with no excessive force used.A second evercross pta balloon was attempted and during initial inflation, balloon burst/leak/rupture occurred at 8atm.Physician used medtronic 5x150 and 6x60 pta balloons, and stents were placed within existing stents to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the evercross pta balloon dilatation catheter was received loosely coiled.Sanguine tinted fluid was observed within the inflation lumen luer lock of the y-manifold and within the balloon chamber.A 30cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed until clear fluid flowed through the distal tip of the catheter.A 0.035¿ compatible guidewire was loaded with ease through the distal tip of the catheter and navigated out the proximal hub with ease.A 30cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and a vacuum could be pulled and maintained.The water filled syringe was pressurized and a pinhole leak was noted at the proximal end of the balloon chamber.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

Image review: a single photographic image of a post-procedural image was provided for analysis.The image confirms that the proximal, mid, and distal superficial femoral artery was treated.In the image several overlapping stents are implanted within a previous stented vessel.Neither evercross pta dilatation catheter is in the context of the image.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: patient age provided.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: balloon burst occurred.The balloon did not fragment and was removed intact.There was no vessel damage.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: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10683665
• MDR Text Key: 212118330
• Report Number: 2183870-2020-00331
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684061640
• UDI-Public: 00821684061640
• Combination Product (y/n): N
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: AB35W06060135
• Device Catalogue Number: AB35W06060135
• Device Lot Number: A739288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 54