MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200086020
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that tip detachment occurred.An 8x60x120 epic¿ vascular stent was selected to treat the lesion.However, during preparation, it was noticed that the tip of the delivery system was detached.The device was never used inside the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6654077
• Report Number: 2134265-2017-06100
• Device Sequence Number: 19215018
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: (01)08714729805687(17)20190228(10)18926446
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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: 02/28/2019
• Device Model Number: H74939200086020
• Device Catalogue Number: 39200-08602
• Device Lot Number: 18926446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1