MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-08-27-135
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: a visipro device was returned evaluation.A bent strut was observed on the returned device in the transportation tray.The visipro device was removed from the tray to conduct further analysis.A proximal stent strut with radiopaque marker hoop was noted to be bent distally when the visi-pro system was removed from its transportation tray.The bend to the strut was observed approximately 1mm distally.Sanguine residue was noted within the balloon chamber and inflation lumen port of the y-manifold.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a visi pro for the treatment of a slightly calcified cto lesion in the right common iliac artery.The ifu was followed and the device prepped without issue.It is reported that the device was unable to cross the lesion.The physician then further dilated the lesion with unknown make of coronary balloons of the following sizes: 1.5x15mm, 2.5x15mm & 3x20mm.The physician completed procedure using another medtronic device.No patient injury was reported.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7326471
• Report Number: 2183870-2018-00136
• Device Sequence Number: 1605548
• Product Code: FGE
• UDI-Device Identifier: 00821684036495
• UDI-Public: 00821684036495
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 04/11/2019
• Device Catalogue Number: PXB35-08-27-135
• Device Lot Number: A259330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR