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

Catalog Number	PMB4-6-14-80
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was attempting to treat a lesion with plaque, little calcification and 80% stenosis with no tortuosity in the renal artery using paramount mini stent.It was reported that balloon inflation/deflation difficulties occurred; the device was slow to deflate at the lesion site.The lesion was predilated.The procedure was completed by deploying the stent.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation: the paramount mini balloon-expandable biliary stent system was received for evaluation within a series of plastic pouches, within its shelf carton, and within a zippered plastic pouch.The paramount system was returned with a 10cc syringe filled with a clear liquid.Sanguine residue was noted on the exterior of the balloon chamber and within the y-manifold guide wire luer lock.No cine images from the procedure were received.A 20cc water filled syringe was attached to the proximal hub of the y-manifold and the guide wire lumen was flushed: sanguine residue and tinted fluid was observed exiting the distal end of the guide wire lumen.The guide wire lumen was flushed until a clear steady stream of fluid was observed exiting the distal end of the catheter.A 0.014¿ guide wire was loaded through the distal end of the catheter with ease.The balloon chamber was inflated with ease using the syringe and fluid returned with the paramount system, (photo 9).A vacuum was pulled and the balloon deflated with ease using the syringe/fluid returned.The balloon chamber was re-inflated with the returned syringe/fluid, a vacuum was pulled and the balloon deflated in approximate 2-seconds, (less than or equal to 90 seconds).The balloon chamber was inflated with ease using a 20cc syringe with manometer and water.The balloon chamber was inflated to nominal pressure of 10atm.A vacuum was pulled and the balloon deflated with in approximately 3 seconds.The balloon chamber was inflated to rated burst pressure of 12atm.A vacuum was pulled and the balloon deflated within approximately 2 seconds.The balloon chamber was inflated with a 50:50 mixture of glycerin and water to replicate a 50:50 saline and contrast mixture using a 10cc syringe.The balloon chamber was inflated with ease.A vacuum was pulled and the balloon deflated within approximately 4 seconds.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6430869
• Report Number: 2183870-2017-00142
• Device Sequence Number: 19068342
• Product Code: FGE
• UDI-Device Identifier: 00821684006399
• UDI-Public: 00821684006399
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2017

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: 08/08/2019
• Device Catalogue Number: PMB4-6-14-80
• Device Lot Number: A324057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided; 03/24/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/20/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR