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

Model Number	PMB8-7-14-80
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a paramount mini balloon expandable stent along with non-medtronic 7fr sheath and 0.014" guide wire during procedure to treat a moderately calcified plaque fibrous lesion in the right proximal renal artery with 90% stenosis.The vessel is moderately tortuous.The vessel diameter and lesion length are 7mm and 15mm respectively.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues noted.The device failed to cross/position.It was reported that the physician attempted to direct stent with the paramount mini; however, the stent would not cross the lesion.Physician took a stent and balloon out and predilated with a 3.0 x 15 coronary balloon.The stent was noted to not be securely positioned on the balloon and the physician elected to use a different paramount mini in its place.The stent was not securely attached to the balloon and was not reinserted in the patient.The device was safely removed from the patient with no difficulties noted during removal.The procedure was completed and the patient was discharged home without injury.A 3.0x15 coronary balloon was used for pre dilation and paramount mini 6x14 was implanted.The device did not pass through a previously deployed stent.There was resistance encountered when advancing the device with no excessive force used.There was no vessel damage noted.There was no patient injury 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: 10683710
• Report Number: 2183870-2020-00333
• Device Sequence Number: 3208239
• Product Code: FGE
• UDI-Device Identifier: 00821684006580
• UDI-Public: 00821684006580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 05/09/2021
• Device Model Number: PMB8-7-14-80
• Device Catalogue Number: PMB8-7-14-80
• Device Lot Number: A643161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1