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

Model Number	H74939293064030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the stent inadvertently deployed.During preparation the 6x40x130mm innova¿ stent inadvertently deployed outside of the patient's body.The procedure was not completed due to another reason and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated 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 outer sheath showed a kink at the nosecone.The middle shaft showed multiple kinks.The pull rack was in the start position.The wheel lock was intact.The stent was not returned inside the device.The ops engineering team opened the handle to inspect for further damage, no further damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 the stent inadvertently deployed.During preparation the 6x40x130mm innova stent inadvertently deployed outside of the patient's body.The procedure was not completed due to another reason and no patient complications were 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: 6619239
• Report Number: 2134265-2017-05595
• Device Sequence Number: 10766506
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: (01)08714729873990(17)20200331(10)20461568
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/18/2017

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: 03/31/2020
• Device Model Number: H74939293064030
• Device Catalogue Number: 39293-06403
• Device Lot Number: 20461568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1