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

Model Number	AB35W07120135
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician was using an evercross pta balloon during the treatment of a 40mm calcified lesion in the common femoral artery (cfa).The artery was 7-9mm in diameter and the degree of tortuosity was mild and calcification was severe.A 6fr non medtronic sheath was used.Embolic protection was not used.The device was prepped as per the ifu with no issues identified.The balloon was inflated using a non medtronic inflation device and contrast/heparin/saline mix 50/50.It was reported initial treatment was at site of left distal sfa and left cfa through right cfa access and up and over sheath.Diagnostic images taken and csi atherectomy performed of aforementioned lesions.Coming back across iliac bifurcation the physician inserted 7mm x 120mm bard 035 pta catheter to treat lesions in bilateral common iliac artery by inflating a single balloon across carina in both iliacs simultaneously.The non mdt balloon ruptured and was removed.The evercross balloon was then inserted and treatment was initiated in same manner described above.The balloon was inflated one time at nominal pressure and ruptured at 7atm and an attempted was made to remove the balloon.  a circumferential/ radial rupture occurred.The balloon had not passed through a previously deployed stent and no resistance was encountered during advancement.It was noted that the balloon was difficult to remove and the balloon had fractured, during withdrawal the catheter caught on the distal end of the sheath.Attempts to remove fractured tip in access side (ipsilateral) failed and patient underwent surgical cutdown for removal, there was damage to the vessel due to the surgical intervention to remove the catheter.All balloon material is thought to be removed with no evidence showing otherwise.No further patient injury reported for this event.
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.
Additional Manufacturer Narrative
Product analysis the device was returned with the proximal end of the balloon still attached to the shaft and the distal end of the balloon and distal section of inner stuck on a 0.035¿ guidewire.The luer and markerbands were not returned 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, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16272270
• Report Number: 2183870-2023-00043
• Device Sequence Number: 20341813
• Product Code: LIT
• UDI-Device Identifier: 00643169974180
• UDI-Public: 00643169974180
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: AB35W07120135
• Device Catalogue Number: AB35W07120135
• Device Lot Number: B145038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male