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

Model Number PCU060300130

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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 ; 091708734
• MDR Report Key: 9881971
• MDR Text Key: 190341983
• Report Number: 9612164-2020-01352
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08033477075891
• UDI-Public: 08033477075891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• Date Device Manufactured: 10/16/2019
• 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