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

Catalog Number SBI080080130

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device returned coiled inside a biohazard bag.Lot number on luer: 220279708.Device was decontaminated with cidex opa solution soak.A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.A 0.035¿ guidewire was loaded through the tip and exited the luer without any difficulty.An indeflator with pressure gauge was used to inflate but the balloon would not hold pressure and a pinhole leak was observed in the centre of the balloon.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use an admiral xtreme pta balloon during procedure to treat moderately calcified lesion in the mid superficial femoral artery.The vessel had little tortuosity.The balloon was inflated with a syringe.There was no damage noted to packaging and no issues when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.It was reported that there were inflation difficulties during inflation at 14 atm.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.No leaks noted on the device.No balloon burst occurred.Device was safely removed from patient.The procedure was completed with another brand of the same balloon.No patient injury reported.A pinhole leak was observed in the centre of the returned balloon.

• Brand Name: ADMIRAL XTREME OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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 ; EI ; 091708734
• MDR Report Key: 13495338
• MDR Text Key: 290569567
• Report Number: 9612164-2022-00527
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2023
• Device Catalogue Number: SBI080080130
• Device Lot Number: 220279708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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 Sex: Male
• Patient Weight: 64 KG