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

Catalog Number	AB35W12060135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
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 attempted to use an evercross pta balloon with a non-medtronic 6fr sheath (cook) and a non-medtronic 0.035' guidewire (abbott) to treat a moderately calcified lesion presenting 70% stenosis in the mid superficial femoral artery.Artery diameter and lesion length were 5mm and 10 mm, respectively.The device was prepped per the ifu.A non-medtronic inflation device (boston) was used to inflate the balloon.The balloon did not passed through a previously deployed stent.No resistance was experienced during advancement.It was reported that a longitudinal balloon burst occurred during first balloon inflation at 7 atm.Another evercross balloon was used to complete the procedure.There is no patient injury reported.
Additional Manufacturer Narrative
Patient date of birth: month and year valid additional information: the vessel treated was the left femoral artery.Negative prep was performed.All parts of the balloon were removed from the patient.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
Product analysis: the evercross was returned for evaluation.No ancillary devices were included.The evercross was removed from the protective hoop and inspected.It could not be determined conclusively if the balloon was inflated previously.No damages or anomalies were observed to the balloon, catheter shaft, or manifold.A 0.035" guidewire was front-loaded with no resistance.An inflation device from the lab was connected to the balloon port and pressure was administered.At 2 atm a leak was observed coming out of the guidewire port of the manifold.Pressure continued while the leak was occurring in efforts to test the balloon.The balloon was able to inflate with no leak noted.The balloon was squeezed by hand and no leak noted.The manifold was assembled and was inspected under directly lighting and removed the strain relief no damage or anomalies were noted.It is likely the leak occurred a hole to the guidewire lumen within the inflation lumen.It could not be determined where specifically the hole was located.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: 8968862
• Report Number: 2183870-2019-00433
• Device Sequence Number: 16774564
• Product Code: LIT
• UDI-Device Identifier: 00821684062340
• UDI-Public: 00821684062340
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2019

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: 02/26/2022
• Device Catalogue Number: AB35W12060135
• Device Lot Number: A789872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 11/15/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 09/23/2019; 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 60