MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Model Number	G34111
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations, "the stent got stuck in the clear sheath.They physician noticed a kink in the clear sheath.Physician indicated this could have been from a stricture or user error on their part.A second stent (lot# c1601025) was opened, and she again had a difficult time getting the stent thru the clear sheath.Both stent were ultimately placed." note: the physician cut the clear outer sheath due to the metallic stent being stuck.The physician did not want to lose access and she needed to get a wire in.
Additional Manufacturer Narrative
This report is being submitted as a cancellation report.Initial assessment erred on the side of caution pending a full investigation.Following lab evaluation of the device it has been confirmed that the clear sheath was had a slight kink.No adverse effects to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Reference: (b)(4) rev.010 section: 3.3.2 "kinks".Overall risk assessed as category iia (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.
Event or Problem Description
As reported to customer relations, "the stent got stuck in the clear sheath.They physician noticed a kink in the clear sheath.Physician indicated this could have been from a stricture or user error on their part.A second stent (lot#: c1601025) was opened, and she again had a difficult time getting the stent thru the clear sheath.Both stent were ultimately placed." note: the physician cut the clear outer sheath due to the metallic stent being stuck.The physician did not want to lose access and she needed to get a wire in.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8974128
• Report Number: 3001845648-2019-00457
• Device Sequence Number: 3295315
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)220402(10)C1601025
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: 04/02/2022
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1601025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1