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

Model Number	H74939200101070
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Age at time of event: over 18 years old.Device evaluated by manufacturer: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that wire entrapment occurred.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified iliac artery.A non bsc guidewire was being advanced through a 10x100x75 epic¿ stent delivery system when the guidewire became stuck midway.The non bsc guidewire and epic¿ stent delivery system were removed as one unit and the procedure was completed with another device.No patient complications were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6364555
• Report Number: 2134265-2017-01487
• Device Sequence Number: 16153838
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: (01)08714729805113(17)20210828(10)0019651951
• Combination Product (Y/N): N
• 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): 02/07/2017

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: 08/28/2021
• Device Model Number: H74939200101070
• Device Catalogue Number: 39200-10107
• Device Lot Number: 0019651951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: RADIFOCUS 035 CRUISE; INTRODUCER SHEATH: TERUMO 6F