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

Catalog Number PCF050150130

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the pacific xtreme pta balloon was returned to medtronic investigation lab for evaluation.The device was returned coiled in its pouch inside a biohazard bag.A visual inspection found the balloon in a pre-inflated state.A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.However, the balloon began to inflate during the flushing indicating a leak between the inner lumen and inflation lumen.The strain relief was removed, and bunching/ damage was visible on the shaft.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use the pacific xtreme pta balloon to treat moderately calcified plaque in the left superficial femoral artery(sfa).The vessel exhibited 85% stenosis and had moderate tortuosity.No embolic protection was used.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.Device was prepped per ifu with no issues.It was reported that there was failure to cross/position.There was severe resistance felt during advancement.No excessive force was used.After the puncture was successful, the 18'' guidewire was inserted and the pacific xtreme pta was selected.The guidewire could not pass through the balloon.The balloon was replaced with same model balloon.The device was safely removed.There was no vessel damage.The guidewire passed through and was positioned at the lesion to expand for 3 minutes then exited the balloon angiography.The blood flow in the original stenosis was smooth and operation finished.No patient injury reported.

• Brand Name: PACIFIC XTREME
• 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: 12793538
• MDR Text Key: 285000122
• Report Number: 9612164-2021-04338
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: PCF050150130
• Device Lot Number: 220855908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/11/2021
• Date Device Manufactured: 09/28/2020
• 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 Age: 80 YR
• Patient Sex: Male