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	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: mid (b)(6).(b)(4).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 33cm and protruding from the proximal end approximately 68cm.The stent was not returned.The guidewire was removed from the device with some restriction.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 was unable to be determined.(b)(4).
Event or Problem Description
Same case as: 2134265-2017-10684.It was reported the stent delivery system became entrapped on the guidewire.A 6 x 200 x 130 innova¿ stent and 035/260 magic torque¿ guidewire were selected for a procedure in the aorta.After the stent was deployed, the stent delivery system became stuck on the wire, so both the stent deployment system and the wire had to be removed together.Wire positioning was lost.They had to re-wire the vessel and continued with the procedure.A 6x100 innova was additionally implanted to stent the full length of the lesion over a bentson wire to complete the procedure.There were no patient complications and the patient was fine.

• 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: 7007561
• Report Number: 2134265-2017-10676
• Device Sequence Number: 1131076
• 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
• Report Date (Section B): 10/12/2017

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: 11/30/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20014164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1