MAUDE Adverse Event Report: AV. PASEO DEL CUCAPAH #10510 ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNK-CV-GWY-SBI

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

Patient Problem Stenosis (2263)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During index procedure a medtronic standard pta was used in the left venous anastomosis.Approximately 5 months post procedure, patient suffered shunt stenosis and revascularization of the venous outflow was carried out using a non-mdt pta device.Patient recovered.Investigator assessed that event is not related to the study device, procedure or therapy.

Manufacturer Narrative

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

Manufacturer Narrative

Event was also treated with medication.Sponsor assessed that the event is not related to the study device, procedure or therapy.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): AV. PASEO DEL CUCAPAH #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): AV. PASEO DEL CUCAPAH #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7316304
• MDR Text Key: 101591369
• Report Number: 9612164-2018-00442
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062809
• 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,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-SBI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• 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): Required Intervention
• Patient Age: 38 YR