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

Catalog Number SBI040040080

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the lot number data printed on the y-manifold is consistent with the lot number data on the pouch label and reported event.The admiral xtreme catheter was visually inspected; no abnormality or deformities were noted.The balloon chamber was received in a post-inflation profile (e.G.Not tightly wrapped or winged).A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold of the catheter and the guidewire lumen was flushed; a clear steady stream of fluid was observed exiting the distal tip of the catheter.A 0.035¿ compatible guidewire was loaded with ease through the distal tip of the catheter and navigated with ease out the proximal hub luer lock of the catheter.A 6cc water filled syringe was attached to the inflation lumen luer lock and a vacuum was pulled, (negative prep); a steady stream of air bubbles filled the syringe.The vacuum could be pulled but not maintained indicating communication between the balloon chamber and inflation lumen with the surrounding environment, (e.G.Leak).The water filled syringe was lightly pressurized and a pinhole leak was noted in the distal third of the balloon chamber.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Physician was using admiral xtreme pta balloon during procedure to treat the avf.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues noted.It was reported that balloon burst occurred during balloon inflation.Physician reported that the balloon would not inflate under angio and after removing from the patient, it was inspected when balloon was found leaking hence, the difficulty inflating.There was already a tear in the balloon.Another product was used to complete treatment.There was no patient injury reported.

• 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: 9563564
• MDR Text Key: 188288152
• Report Number: 9612164-2020-00147
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2021
• Device Catalogue Number: SBI040040080
• Device Lot Number: 216044842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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