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

Model Number	H74939293061030
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation by manufacturer: an innova self-expanding stent delivery system (sds) was returned with a.035 unidentified guidewire inside of the device.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The outer sheath had a slight buckling at the nosecone.The stent was not returned.The guidewire that was frozen in the device was protruding out of the distal end approximately 5cm from the tip and protruding out of the proximal end approximately94.5cm.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported withdrawing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.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
Same case as mdr id #2134265-2017-02149.It was reported that wire entrapment occurred.The target lesion was located in a totally occluded right superficial femoral artery (sfa).The lesion was pre-dilated with a 4x200mm mustang balloon catheter and then with a 5x150mm lotunix drug coated balloon.A 6 x100x130mm innova stent was advanced to the lesion and the stent was deployed.During removal, the delivery system wouldn¿t come off of 250 magic torque wire so the physician had to pull the entire system out with the wire stuck inside the deployment system.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: 6411006
• Report Number: 2134265-2017-02148
• Device Sequence Number: 925036
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: (01)08714729874027(17)20190331(10)18988344
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 02/27/2017

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: 03/31/2019
• Device Model Number: H74939293061030
• Device Catalogue Number: 39293-06103
• Device Lot Number: 18988344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR