MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293071030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the stent deployed inadvertently.A 7 x 100 x 130 innova¿ was selected for a procedure.During preparation, while injecting saline in the yellow flush port, the stent came out of the sheath.The stent was not used on the patient.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The outer sheath was kinked at the nosecone.No damage was noticed on the mid-shaft.The stent was returned inside the device and was partially deployed approximately 8mm from the markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is considered handling damage as the event occurred prior to patient contact.Bsc id (b)(4)/tw 4814419.
Event or Problem Description
It was reported that the stent deployed inadvertently.A 7 x 100 x 130 innova¿ was selected for a procedure.During preparation, while injecting saline in the yellow flush port, the stent came out of the sheath.The stent was not used on the patient.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6988874
• Report Number: 2134265-2017-10570
• Device Sequence Number: 118274
• Product Code: NIP
• UDI-Device Identifier: 08714729874119
• UDI-Public: 08714729874119
• 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): 10/09/2017

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: 01/31/2020
• Device Model Number: H74939293071030
• Device Catalogue Number: 39293-07103
• Device Lot Number: 20176449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1