MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Device Problem Burst Container or Vessel (1074)

Patient Problems Hematoma (1884); Vascular Dissection (3160); Swelling/ Edema (4577)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Title: rupture, breakdown, and pulmonary artery embolism of a balloon catheter tip during percutaneous transluminal angioplasty of arteriovenous 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.Average age, majority gender, of publication.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 fortrex balloon was used.The patient was admitted for dialysis conduit dysfunction.The left upper arm avf was created 8 years prior in the brachial artery and cephalic vein.Ultrasonography revealed severe stenosis of the cephalic arch with normal dilation of the left upper arm dialysis conduit.A 6fr sheath was inserted into the mid-portion of the upper arm cephalic vein.Venography revealed severe stenosis of the cephalic arch.A guidewire was passed through the stenotic lesion and pta was performed using a fortrex balloon.It is reported prior to applying burst pressure, the balloon catheter ruptured with partial vein tearing.Venotomy of the puncture site was immediately performed to remove the ruptured balloon catheter.Subsequently, 8-mm balloon tamponade in the cephalic arch was performed for 10 minutes.After confirming hemostasis of the cephalic arch with venography, the venotomy site was closed.The patient was admitted for 7 days because of left chest wall swelling and mild hematoma.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• 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: 10968411
• MDR Text Key: 220634584
• Report Number: 2183870-2020-00426
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR