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

Model Number	AB35W06100135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use an evercross pta balloon and nanocross elite pta balloon during treatment of a 200mm lesion in the patient¿s mid left superficial femoral artery (sfa).Heavy calcification and minimal tortuosity are reported.Lesion exhibited 90% stenosis.The vessel diameter is reported as 6mm.There was no damage noted to the product(s) packaging prior to use nor any issues noted when removing the devices from the packaging.Ifu was followed and the devices were prepped without issue.A 5fr non-medtronic sheath and 0.014 non-medtronic guidewire were used during the procedure.The balloons were inflated with a non-medtronic inflation device and 50/50 fluid solution.The devices were not passed through a previously deployed stent.No resistance was felt during advancement of the devices.It is reported that a pinhole burst occurred on both the evercross pta balloon and the nanocross elite pta balloon.The evercross pta balloon is reported to have burst at 8atm and the nanocross elite pta balloon is reported to have burst at 10atm.The procedure was then completed with a non-medtronic stent and balloon.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the devices were safely removed with no intervention required.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.
Additional 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.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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11123010
• Report Number: 2183870-2021-00008
• Device Sequence Number: 19024427
• Product Code: LIT
• UDI-Device Identifier: 00763000184445
• UDI-Public: 00763000184445
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: AB35W06100135
• Device Catalogue Number: AB35W06100135
• Device Lot Number: A951205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 02/11/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/07/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 111