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.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• 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
• Reporter Country Code: KS
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• 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

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/08/2020 Patient Sequence Number: 1