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

Model Number	PCU060300130
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
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 used a pacific xtreme pta balloon with a non-medtronic 6fr sheath and 0.014 guidewire during treatment of a >250mm plaque lesion in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm.Moderate vessel calcification is reported.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.It is reported balloon inflation difficulties were noted.The balloon appeared to be stuck to the catheter.A balloon twist is reported.Procedure was completed with same balloon.The physician advanced to and inflated where it was sticking to catheter.No vessel damage was noted.The device was safely removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
Image review: two photographic images were received for evaluation.The first image is of a procedural cine image of the patient¿s mid right superficial femoral artery based on anatomical landmarks.In the cine image the pta balloon catheter is inflated and three balloon twists ¿candy wrapping¿ are visible.The second image the pta balloon catheter has been removed from the patient and is inflated.In this photograph at the proximal end of the balloon chamber there are only two balloon twists ¿candy wrapping¿.It is noted that the inner guidewire lumen is undulating within the balloon chamber an indication that the balloon may have been over inflated.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: 9881971
• Report Number: 9612164-2020-01352
• Device Sequence Number: 492558
• Product Code: LIT
• UDI-Device Identifier: 08033477075891
• UDI-Public: 08033477075891
• 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): 04/23/2020

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: 10/16/2022
• Device Model Number: PCU060300130
• Device Catalogue Number: PCU060300130
• Device Lot Number: 218712741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1