MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26924
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 14sep2018.The 7 x 20 x 130 innova was returned with no known complaint.However, device analysis found the device was stuck on the guidewire.Device eval by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, middle shaft, and the remainder of the device were checked for damage.The device showed that a guidewire was stuck in the device.The mid-shaft was kinked 23cm from the distal side of the markerband.There was a kink and buckling at the nosecone.There was buckling 2cm from the nosecone.There was a kink on the inner liner located at 10cm from the tip.There was no stent in the device when returned.The guidewire sticking is consistent with the buckling damage constricting down on the wire and inhibiting it from exiting the catheter shaft.Inspection of the remainder of the device, revealed no other damage or irregularities.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7935103
• Report Number: 2134265-2018-61600
• Device Sequence Number: 1585839
• Product Code: NIP
• UDI-Device Identifier: 08714729874072
• UDI-Public: 08714729874072
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 09/17/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021145026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/04/2018
• Patient Sequence Number: 1