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

Catalog Number	PXB35-08-37-135
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.The visi-pro was received loaded in the 6fr non-medtronic introducer sheath.Balloon material was bunched up at the distal end of the balloon.The visi-pro catheter was advanced distally out of the sheath.Sanguine residue was noted on the exterior of the balloon chamber.A small amount of contrast residue was noted in the distal end of the balloon chamber.The sheath was examined and the distal end exhibited accordion folding.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a visi-pro balloon-expandable stent to treat a lesion in the common iliac artery.The device was removed from its packaging and inspected with no issues noted.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used.The stent was deployed correctly without any issue, but the balloon got stuck in the sheath after the stent was deployed.The procedure was finished without further issue.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: 7246773
• Report Number: 2183870-2018-00065
• Device Sequence Number: 16401994
• Product Code: FGE
• UDI-Device Identifier: 00821684036518
• UDI-Public: 00821684036518
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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: 05/21/2020
• Device Catalogue Number: PXB35-08-37-135
• Device Lot Number: A463698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1