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

Catalog Number SBI050040150

Device Problem Burst Container or Vessel (1074)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was using an admiral xtreme pta balloon catheter to treat a lesion.It was reported that during procedure, physician encountered difficulty with the device.The balloon burst in the patient and balloon fragments remained in patient.Physician surgically removed the fragment.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: the distal assembly of the admiral xtreme pta balloon catheter was received in a nested series of sealed sterilization pouches and loosely coiled within a zippered closure pouch that included a peel-off label.The admiral xteme was received loaded on a guidewire that was locked up in two different introducer sheaths.A pk energy device 5.0/30 ancillary device was received loaded through one of the introducer sheaths.The distal assembly of the admiral xtreme was protruding from the distal end of this introducer sheath.Visual examination of the distal assembly of the admiral xtreme revealed that all distal components of the admiral xtreme were accounted for; distal tip, two radiopaque marker bands, and balloon chamber material.The balloon chamber material exhibited bunching up at the proximal end of the balloon chamber.The balloon chamber and admiral xtreme catheter material exhibited longitudinal tearing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME OTW
• 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: 9144431
• MDR Text Key: 160842800
• Report Number: 9612164-2019-04183
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173515
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Catalogue Number: SBI050040150
• Device Lot Number: 214685074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• 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