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

Model Number	26926
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent became stuck on the wire.A 7x150x130 innova stent was selected for use.The stent was deployed, however, the inner lumen of the innova became stuck on the non-bsc guidewire.The device was attempted to be removed from the guidewire but it was unsuccessful.The physician then forcefully broke apart the innova delivery system and was able to remove the entire system in pieces, and the guidewire was removed as well.A new guidewire was inserted and the procedure was completed by ballooning the innova.There were no patient complications reported.
Event or Problem Description
It was reported that the stent became stuck on the wire.A 7x150x130 innova stent was selected for use.The stent was deployed, however, the inner lumen of the innova became stuck on the non-bsc guidewire.The device was attempted to be removed from the guidewire but it was unsuccessful.The physician then forcefully broke apart the innova delivery system and was able to remove the entire system in pieces, and the guidewire was removed as well.A new guidewire was inserted and the procedure was completed by ballooning the innova.There were no patient complications reported.Device evaluated by mfr: the outer sheath was kinked at the nosecone.The mid shaft showed a kink located at 9.5cm from the proximal side of the marker band.The proximal inner shaft was separated from the device and was returned.The inner liner was separated from the device and not returned.The tip is part of the inner liner portion that was detached, so the tip was detached from the device and not returned.The stent was not returned.The handle was separated to inspect for further damage, and no other damage was noticed.The guidewire sticking issue may have been caused by the device being kinked at the nosecone during the procedure or an adverse event during the procedure.The separations were caused by possible intoducer sheath interference when the procedure was completed.Inspection of the remainder of the device, apart from the observed damage, 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: 8020625
• Report Number: 2134265-2018-62324
• Device Sequence Number: 16417320
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 02/01/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0021693654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1