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

Catalog Number SBI100040130

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use an admiral xtreme device during treatment of the patient¿s left subclavian artery.Slight tortuosity is reported.Vessel described as stenosed.An inflation device was used.Ifu was followed.No issues were noted during prep.The device was not passed through a previously deployed stent.No resistance was encountered during advancement.It is reported that removal difficulties were experienced when attempting to remove the device due to the device being slow to deflate.Excessive force was used at time of removal.The balloon was removed successfully.This issue is reported to have occurred for two admiral xtreme devices.

Manufacturer Narrative

Vessel described as 90% stenosed.Inflation device was used for 3 inflations at 8atm.The sheath was inserted further to cover the balloon for removal.No issues noted during prep, no inflation issues noted, no twist observed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the admiral xtreme was received with the balloon chamber in a post-inflated stated; it was noted that crystalline residue remained in the balloon chamber.The lot identification printed on the manifold matches the lot identification on the shelf carton and event description.A 20cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed; a clear and steady stream of fluid was observed exiting the distal tip of the catheter.A 0.035¿ guidewire was loaded through the distal tip and navigated out the proximal hub with ease.A 20cc water filled syringe was attached to the inflation lumen luer lock and a vacuum was able to be pulled and maintained; indicating no communication with the environment (e.G.Leak).A 20cc water filled syringe with manometer was attached to the inflation lumen luer lock and the balloon was inflated to 8-atm, (greater than nominal pressure 6-atm but the pressure used in the reported procedure).No leaks were detected.The balloon chamber fully deflated in approximately 19-seconds.The returned inflation device with contrast solution was attached to the inflation lumen luer lock and the balloon catheter was inflated to 8-atm, (reported event pressure).A vacuum was pulled, and the balloon chamber fully deflated in 1-minute and 3-seconds.A 50:50 glycine:water solution was prepared and placed in an inflation device.The inflation device was attached to the luer lock and the balloon catheter was inflated to 8-atm, (reported event pressure).A vacuum was pulled, and the balloon chamber fully deflated in 1-minute and 22-seconds.The returned admiral xtreme device performed as intended.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; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8744338
• MDR Text Key: 149513420
• Report Number: 9612164-2019-02590
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: SBI100040130
• Device Lot Number: 213943641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• 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