MAUDE Adverse Event Report: MEDINOL LTD X-SUIT NIR BILIARY METALLIC STENT; BILLIARY STENT

Model Number	8X80
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the case initiation, several attempts were made to obtain additional information.Despite our efforts, the attempts were unsuccessful and no additional information achieved.
Event or Problem Description
According to the initial case report form received on may 16, 2019: this complaint was initiated using interim model name (uncovered type) since the product name is unknown.The event happened out of us in the radiography, the customer found that the stent of x-suit nir was broken.No additional information about the complaint is available at this time.There wasn't any injury to patient.The condition of the patient is ok.
Additional Manufacturer Narrative
Additional information received from the distributor on july 4, 2019 have revealed that the initially reported complaint, which occurred in a site outside the united states and was related to the malfunction of a x-suit nir device was miss-identified.Investigation findings indicated that the complaint reported, was in fact associated to the x-suit nir covered device and not to x-suit nir as initially reported.The x-suit nir covered is not cleared by the fda and therefore not distributed in the united states - medinol does not consider both devices as similar.Hence, the event should not be reported to us health authorities.There was no injury to the patient.The condition of the patient is ok.

• Brand Name: X-SUIT NIR BILIARY METALLIC STENT
• Common Device Name: BILLIARY STENT
• Manufacturer (Section D): MEDINOL LTD; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 8682162
• Report Number: 3003084171-2019-00009
• Device Sequence Number: 2232455
• Product Code: FGE
• UDI-Device Identifier: 04953170270703
• UDI-Public: 04953170270703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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 Model Number: 8X80
• Device Catalogue Number: SME-200P-08080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1