MAUDE Adverse Event Report: COVIDIEN PARAMOUNT MINI GPS BALLOON-EXPANDABLE BILIARY STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PMB4-6-18-80
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the paramount mini balloon-expandable biliary stent system was received for evaluation.No ancillary devices or cine images from the procedure were received.The18mm length stent was received crushed which could be attributed to the use of the snare.The paramount mini stent delivery system was examined visually and tactilely: no abnormality or deformity noted.The balloon chamber was received in a pre-inflation profile.Witness marks of the crimped stent were noted on the balloon chamber material.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 0.014¿ guidewire was loaded through the distal tip with ease and navigated out the y-manifold luer lock.A 10cc water filled syringe was attached to the y-manifold inflation lumen luer lock, a vacuum was able to be pulled and maintained.A 20cc water filled syringe was attached to y-manifold inflation lumen luer lock and the balloon chamber was able to be inflated to its nominal pressure of 10atm.The balloon chamber was then inflated to its rated burst pressure of 14atm.The paramount mini was able to be inflated to its nominal and rated burst pressures.A vacuum was pulled, and the balloon chamber was able to fully deflate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a paramount mini balloon expandable stent system during treatment of a tight and tortuous lesion in the patients renal artery.Some calcium was present.The ifu was followed during prep and use of the device.An inflation device was attached but not used as it is reported that the stent dislodged during delivery to the lesion.It is reported the dislodged stent was removed using a snare.A second paramount mini was successfully delivered to the lesion site and deployed without issue.No patient injury was reported.

• Brand Name: PARAMOUNT MINI GPS BALLOON-EXPANDABLE BILIARY STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7933520
• Report Number: 2183870-2018-00456
• Device Sequence Number: 13667163
• Product Code: FGE
• UDI-Device Identifier: 00821684006429
• UDI-Public: 00821684006429
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2019
• Device Catalogue Number: PMB4-6-18-80
• Device Lot Number: A342713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention