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

Catalog Number SBI040060130

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a admiral xtreme for patient treatment.The right artery had a diameter of 3 mm.Ifu was followed.A syringe was used for balloon inflation.No damage was noted to the packaging.No issues noted when removing the device from the hoop/tray.The device did not pass through a previously-deployed stent.There was resistance encountered when advancing the device.There was no excessive force used.It was reported there was balloon inflation difficulties.The balloon was inflated to nominal pressure.Device damage (leak/hole) was noted on the body of the balloon.The device was safely removed from the patient.The procedure was completed with a new admiral xtreme balloon.There was no patient injury reported.

Manufacturer Narrative

Product analysis #703848195:the admiral xtreme pta balloon catheter was received within its opened labeled shelf carton, along with the label portion of its labeled pouch, within a knotted closed plastic pouch, and loosely coiled within a plastic pouch, (see 73848195-10 photos 1-8).No ancillary devices nor procedural images were provided for analysis.The admiral xtreme pta balloon catheter was received with the balloon in a post-inflation profile, (e.G.Not tightly wrapped nor winged) (photo 8).A 20cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold.A vacuum could be pulled but not maintained.The syringe was lightly pressurized and a leak just distal of the y-manifold was noted.Technical analysis of the returned admiral xtreme pta balloon catheter confirmed inflation difficulties due to a leak in the catheter just distal of the y-manifold.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10325019
• MDR Text Key: 200409505
• Report Number: 9612164-2020-02729
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Catalogue Number: SBI040060130
• Device Lot Number: 216566178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 68