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

Model Number	H74939293071830
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the device became entrapped on the guidewire.An innova¿ self expanding stent was selected for a stenosis dilation procedure in the superficial femoral artery.The stent was placed using a non-bsc guidewire with an extension attached.It felt difficult to pull during placement when pulling the pull grip.However, they were able to deploy the stent and the procedure was completed with this device.After placement, they were unable to pull out the device with the guidewire over the catheter from the sheath.The guidewire and catheter had to be pulled out together.It appeared that the extension became stuck in the internal part of the innova grip.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an innova self-expanding stent delivery system (sds) with a.014 guidewire stuck inside of the device.The outer shaft, middle shaft, inner sheath, and the remainder of the device were checked for damage.There was a kink at the nosecone.The stent was not returned.The.014 guidewire that was frozen in the device was not protruding out of the tip.The guidewire was protruding out of the proximal end of the device approximately 153cm.There was a kink on the inner shaft approximately 4cm from the tip.The handle was opened to visually inspect the proximal inner shaft for prolapsing which could cause a guidewire to stick in the device.There was prolapsing present.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 the device became entrapped on the guidewire.An innova¿ self expanding stent was selected for a stenosis dilation procedure in the superficial femoral artery.The stent was placed using a non-bsc guidewire with an extension attached.It felt difficult to pull during placement when pulling the pull grip.However, they were able to deploy the stent and the procedure was completed with this device.After placement, they were unable to pull out the device with the guidewire over the catheter from the sheath.The guidewire and catheter had to be pulled out together.It appeared that the extension became stuck in the internal part of the innova grip.There were no patient complications.

• 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: 6111346
• Report Number: 2134265-2016-10263
• Device Sequence Number: 19008769
• Product Code: NIP
• UDI-Device Identifier: 08714729874140
• UDI-Public: (01)08714729874140(17)20190630(10)19408969
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2016

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: 06/30/2019
• Device Model Number: H74939293071830
• Device Catalogue Number: 39293-07183
• Device Lot Number: 19408969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 12/08/2016
• 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: PARENT PLUS 6FR 48CM INTRODUCER SHEATH; TREASURE FLOPPY .018 GUIDEWIRE