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

Model Number	H74939293062030
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the catheter was stuck on the guidewire.A 6 x 200 x 130 innova¿ stent was selected for a procedure in the superficial femoral artery (sfa).After the stent was deployed, the delivery catheter could not be removed over the.035 non-bsc wire.The wire was stuck in the catheter.The entire system was removed.The procedure was completed with this stent.There were no patient complications and the patient's status was reported as fine and healthy post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds) with a.035 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.There was a.035 guidewire stuck in the lumen of the device that was protruding out from the tip approximately 9cm and protruding from the proximal end approximately 94cm.The stent was not returned.The handle was opened to inspect for internal damage.There was damaged noticed on the mid-shaft approximately 15cm from the retainer clip that was causing a restriction on the guidewire and caused the guidewire to stick in the catheter shaft.The damage may have been caused by the procedural factors.The damage was a compression in the mid-shaft.The stuck wire was confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 catheter was stuck on the guidewire.A 6 x 200 x 130 innova¿ stent was selected for a procedure in the superficial femoral artery (sfa).After the stent was deployed, the delivery catheter could not be removed over the.035 non-bsc wire.The wire was stuck in the catheter.The entire system was removed.The procedure was completed with this stent.There were no patient complications and the patient's status was reported as fine and healthy post procedure.

• 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: 6918847
• Report Number: 2134265-2017-09657
• Device Sequence Number: 1251151
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: 08714729874065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: 08/10/2020
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20997424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1