MAUDE Adverse Event Report: INVATEC SPA REEF; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNK-CV-GWY-REEF

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure the left anastomosis was pre-dilated with a medtronic balloon and treated with a medtronic standard pta balloon catheter.Approximately 9 months post index procedure, patient suffered a high grade stenosis of the avf in the juxta anastomotic region.The patient was treated with medication and a non medtronic pta in the anastomosis.The investigator assessed this event as not related to the index device, procedure or paclitaxel.The event is resolved.

Manufacturer Narrative

During the index procedure a reef balloon catheter was used to treat the anastomosis.Safety assessed the event as not related to the index device, procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The anastomosis was further treated with a non-mdt pta.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Cec adjudicated event as not related to procedure or therapy but related to device.Revascularization is clinically driven.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REEF
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7634152
• MDR Text Key: 112188668
• Report Number: 9612164-2018-01530
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092361
• 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,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-REEF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2018
• 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; Other; Required Intervention
• Patient Age: 81 YR