MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNK-CV-GWY-PCF

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

Patient Problem Occlusion (1984)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revascularisation of the distal sfa and pop1 segments were carried out using one pacific xtreme pta balloon, one in.Pact pacific paclitaxel balloon catheters and a non mdt stent.Approximately 16 months post revascularisation, the patient suffered occlusion of the distal arterial popliteal right outside target lesion.The right leg was treated with one in.Pact pacific balloon catheter and a non mdt pta.The event is resolved.Investigator indicated that event was not related to device or paclitaxel.

Manufacturer Narrative

The occlusion was treated with deb and rotarex.The investigator assessed that the event was also not related to index procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec assessed the event as related to the device and not related to the procedure or paclitaxel medication.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7224813
• MDR Text Key: 98464509
• Report Number: 9612164-2018-00162
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103464
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-PCF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 11/20/2018
• Supplement Dates FDA Received: 03/26/2018; 12/14/2018
• 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; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 70