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

Catalog Number AB35W08060080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Stenosis (2263)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure one in.Pact admiral paclitaxel eluting balloon catheter was used to treat the swing point of the left arm.Approximately 2 months post index procedure the patient suffered from excessive bleeding from fistula post dialysis.The event was described as avf stenosis and repair.Fistulogram corrected the issue.A fistulogram was performed and the swing point was treated with a non mdt pta.The patient recovered.The investigator reported that the event is not related to the index device, procedure or paclitaxel.

Manufacturer Narrative

Device used during index procedure was a medtronic admiral xtreme standard pta balloon catheter.Sponsor assessed the event is not related to the index device, procedure or paclitaxel.The revascularization to treat the event was carried out (18 jan 2018).Cec adjudicated the event as not related to the procedure, device or therapy and the revascularization as clinically driven target lesion revascularization.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: an evercross balloon was used during index procedure.Lot number provided.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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7509974
• MDR Text Key: 108084095
• Report Number: 9612164-2018-01056
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: AB35W08060080
• Device Lot Number: A488577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• Date Device Manufactured: 07/10/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR