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

Device Problem Burst Container or Vessel (1074)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A journal article was submitted detailing a patient case report.Medtronic¿s evercross pta balloon and gooseneck snare devices were used.The patient underwent balloon angioplasty of the left avg which has been placed 2 years previously in the brachial artery and axillary vein.The evercross pta balloon was inflated to burst pressure for 3 minutes in the tight stenotic venous anastomotic site and ruptured.A removal attempt was made through the femoral sheath, the balloon catheter was jammed and fell apart via the right femoral approach site.The migrated tip was stuck at the left upper interlobar pulmonary artery.Initially the remaining balloon catheter was removed by cutdown of the femoral vein.Subsequently, via the left main pulmonary artery using bent-tip angiocatheters with guidewire passage an attempt was made to recapture the ruptured balloon catheter tip using a gooseneck snare.Despite several trials, the balloon tip was buried deeper into the left main pulmonary artery.The balloon tip was removed from the pulmonary artery by open thoracotomy because the patient had complained of mild dyspnea and anxiety.Lateral thoracotomy was performed by the thoracic surgeon to remove the embolized balloon tip.The patient was discharged without complication after 7 days.A new avg was inserted in the right arm after 2 months.

Manufacturer Narrative

Title: rupture, breakdown, and pulmonary artery embolism of a balloon catheter tip during percutaneous transluminal angioplasty of a rteriovenous fistula journal: vascular specialist international authors: young min han, kun yung kim, byeoung hoon chung year: 2019 vol <(>&<)> issue: 35(4) ref: doi: 10.5758/vsi.2019.35.4.245 a2: average age a3: majority gender b3: date of publication 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: 10967923
• MDR Text Key: 220425009
• Report Number: 2183870-2020-00421
• Device Sequence Number: 1
• Product Code: LIT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR