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

Model Number	H74939293061530
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr 2134265-2018-01887.It was reported that the device was stuck on the wire.A 6 x 150 x 130 innova¿ and a 0.035x260 magic torque¿ guidewire were selected for a balloon and stent procedure in the superficial femoral artery (sfa).During the procedure, the stent was deployed.While attempting to remove the device, the catheter became difficult to retract over the wire.The physician pulled the delivery catheter and the wire out together.There were no patient complications reported and the patient¿s condition post procedure was fine.
Additional Manufacturer Narrative
Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).A.035 guidewire was returned with the device.The guidewire showed a kink at 89cm from the tip.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.There was a kink at the nosecone of the device.There was no wire stuck in the device when returned.The.035 guidewire was inserted into the device and the wire transcended through the device with no hesitations or restrictions until it reached the kink where it did have difficulty transcending through the rest of the way through the device.The stent was not returned.The stuck wire was confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
Same case as mdr 2134265-2018-01887.It was reported that the device was stuck on the wire.A 6 x 150 x 130 innova¿ and a 0.035x260 magic torque¿ guidewire were selected for a balloon and stent procedure in the superficial femoral artery (sfa).During the procedure, the stent was deployed.While attempting to remove the device, the catheter became difficult to retract over the wire.The physician pulled the delivery catheter and the wire out together.There were no patient complications reported and the patient¿s condition post procedure 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: 7338901
• Report Number: 2134265-2018-01886
• Device Sequence Number: 1812883
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/21/2018

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: 06/21/2020
• Device Model Number: H74939293061530
• Device Catalogue Number: 39293-06153
• Device Lot Number: 20800463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR