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

Model Number	PCU070150130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2020
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
Physician was attempting to use a pacific xtreme pta balloon catheter during procedure to treat a moderately calcified lesion in a mid vessel.The vessel diameter and lesion length are 7mm and 150mm respectively.There was no damage to packaging.No issues noted while removing device from hoop/tray.The device was inspected with no issues noted.Negative prep was performed with no issues identified.The balloon ruptured at 6 am during first inflation.The vessel was pre dilated.The device passed through a previously deployed stent.No resistance encountered while advancing the device.It was reported that the ballon ruptured at 6atm.The balloon was being used to post dilate a stent when it ruptured.The device was removed intact with no harm to the patient.A subsequent 7x150x130 pacific xtreme pta was used with issues to adequately post dilate the stent.The procedure was completed without any complications achieving an excellent result with no harm to the patient.There was no patient injury reported.
Additional Manufacturer Narrative
Device evaluation: a 10cc water filled syringe was attached to the y-manifold proximal hub luer lock and the guidewire lumen was flushed; a clear steady stream of fluid was observed exiting the distal end of the catheter.A 0.018¿ guidewire was loaded through the distal tip and navigated out the y-manifold proximal hub with ease.Visual examination of the balloon chamber revealed sanguine fluid within the balloon chamber and a slight twist in the balloon chamber material.A 10cc water filled syringe was attached to the y-manifold inflation lumen luer lock and a vacuum was pulled but could not be maintained indicating communication between the inflation lumen and environment, (e.G.Leak).The water filled syringe was pressurized and sanguine fluid was observed exiting a pinhole leak in the balloon chamber.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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9977385
• Report Number: 9612164-2020-01614
• Device Sequence Number: 16911760
• Product Code: LIT
• UDI-Device Identifier: 08033477075914
• UDI-Public: 08033477075914
• 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
• Report Date (Section B): 08/04/2020

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: 01/27/2023
• Device Model Number: PCU070150130
• Device Catalogue Number: PCU070150130
• Device Lot Number: 219377667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1