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

Catalog Number	AB35W04200135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
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
The physician was using an evercross balloon to treat a calcified plaque lesion in the superficial femoral artery (sfa).Little tortuosity was reported but no abnormalities in relation to anatomy.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped per ifu with no issues.It was reported that a pin hole balloon burst occurred during inflation to 8atm using a syringe.All fragments of the balloon was retrieved.The procedure was completed using another device.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: negative prep was performed without any issue noted.The balloon was normally removed through the sheath.No intervention was 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
Device evaluation: the catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped or winged).Sanguine residue was noted within the balloon chamber and y-manifold.All marker bands were present and intact.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed; a clear steady stream of fluid was observed exiting the distal tip of the catheter.Per the reported event, a pin hole balloon burst occurred during inflation to 8atm using a syringe.In other to replicate the reported event, a 0.035¿ guidewire was loaded with ease through the distal tip of the catheter and navigated out the proximal hub of the y-manifold.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold.The balloon chamber was inflated, and multiple pinhole leaks were located in the balloon.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: 8543525
• Report Number: 2183870-2019-00182
• Device Sequence Number: 312204
• Product Code: LIT
• UDI-Device Identifier: 00821684061305
• UDI-Public: 00821684061305
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

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: 07/12/2021
• Device Catalogue Number: AB35W04200135
• Device Lot Number: A675204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 04/26/2019; 07/18/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/21/2019; 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1