MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number ADM070080130

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

Patient Problems Muscle Spasm(s) (1966); Patient Problem/Medical Problem (2688)

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

During the index procedure, a medtronic balloon was used to treat a lesion in the right cephalic arch. On the same day, vessel spasm occurred in the mid cephalic vein after treatment of target lesion requiring ballooning. The investigator assessed the event as casually related to the index device, procedure and antiplatelet medication. The patient recovered.

Manufacturer Narrative

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

Manufacturer Narrative

The investigator assessed the event as not related to the therapy. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ADMIRAL XTREME US
• 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: 7909039
• MDR Text Key: 121704286
• Report Number: 9612164-2018-02529
• 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,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: ADM070080130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/26/2018 Patient Sequence Number: 1