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

Catalog Number	PMB8-6-14-80
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
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
It was reported an expired paramount mini was implanted in the patient¿s renal artery as the dating wasn¿t noticed.The device was prepped without issue.The stent was deployed successfully.No adverse event reported for the patient.
Additional Manufacturer Narrative
Image review: the customer provided an image of the paramount mini gps pouch label.The sterile pouch label showed the device lot number a183725, consistent with the reported device.The ¿use-by¿ date indicated on the label was 2018-11-04.The ¿use-by¿ date listed on the sterile pouch label was consistent with the ¿use-by¿ date listed in the manufacturing records.There was writing in the upper corner of the label indicating that the device was expired.No anomalies were noted with the sterile pouch label; both the lot number and ¿use-by¿ date on the label were correct, clear, and legible.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: no part of the packaging or labeling was damaged or unclear.The patient did not require any additional treatment.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: 8141512
• Report Number: 2183870-2018-00571
• Device Sequence Number: 16549430
• Product Code: FGE
• UDI-Device Identifier: 00821684006573
• UDI-Public: 00821684006573
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K040653
• 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,Followup,Followup
• Report Date (Section B): 03/20/2019

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: 11/04/2018
• Device Catalogue Number: PMB8-6-14-80
• Device Lot Number: A183725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 03/18/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 12/13/2018; 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1