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

Catalog Number	PCU040300130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a 4x300x130 pacific xtreme pta balloon to treat a moderately calcified non tortuous 200mm lesion in the distal superficial femoral artery(sfa).Vessel diameter reported as 4mm.The artery diameter and lesion length were reported to be 4mm <(>&<)> 200mm, respectively.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 6fr sheath and a 45cm non-medronic guidewire were used with no embolic protection.The device was inflated with a non-medtronic inflation device and 50/50 contrast/saline solution was used as inflation fluid.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.The pacific xtreme pta balloon was inflated and ruptured.A 4x250x130 pacific xtreme pta balloon was used without incident to complete the procedure successfully.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation several kinks were noted in the balloon area of the proximal end of the balloon chamber of the balloon catheter, and the inner guidewire lumen exhibited tensile stretching within the balloon chamber.A 10cc water filled syringe was attached to the proximal hub luer lock of the balloon catheter y-manifold and the guidewire lumen was flushed: a clear steady stream of fluid was observed exiting the distal tip of the balloon catheter.A 0.018¿ guidewire was loaded through the distal tip and navigated out the proximal hub of the y-manifold with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and a vacuum was pulled.A steady stream of air bubbles was observed entering the syringe indicating communication between the inflation lumen and the environment, (e.G.Leak).The syringe was lightly pressurized to inflate the balloon chamber of the balloon catheter and a pinhole leak was found about the middle of the balloon chamber length.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received reported that the balloon burst at nominal pressure.No issues with any pieces detaching or embolizing.No issues with removing the device from the patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8310105
• Report Number: 9612164-2019-00437
• Device Sequence Number: 2229849
• Product Code: LIT
• UDI-Device Identifier: 08033477058429
• UDI-Public: 08033477058429
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: PCU040300130
• Device Lot Number: 214899165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/06/2019; 07/02/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/04/2019; 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1