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

Model Number	H74939293076030
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-06682 it was reported that the catheter became stuck on the guidewire.The target lesion was located in the superficial femoral artery (sfa).A 7 x 60 x 130 innova¿ stent was selected for use.The stent delivery system (sds) became stuck on the guidewire when it was being removed from the patient.Wire access was lost.A second 7 x 60 x 130 innova¿ stent was then selected for use; however, the same issue occurred.The procedure was completed with a third 7 x 60 x 130 innova¿ stent.There were no patient complications and the patient condition is fine.
Additional Manufacturer Narrative
Device evaluated by mfr.Returned product consisted of an innova self-expanding stent delivery system (sds) with a.035 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 buckling/kink at the nosecone.The stent was not returned.The guidewire that was frozen in the device was protruding out of the distal end approximately 79.5cm from the tip and protruding out of the proximal end approximately 21cm.The guidewire was separated from the handle by manipulating the shaft.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.Bsc id: (b)(4), tw: (b)(4).
Event or Problem Description
It was further reported that the guidewire used was a magic torque wire.The third 7 x 60 x 130 innova¿ stent was used with a different guidewire.Lesion characteristics were minimal.

• 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: 6701965
• Report Number: 2134265-2017-06681
• Device Sequence Number: 57107
• Product Code: NIP
• UDI-Device Identifier: 08714729874096
• UDI-Public: (01)08714729874096(17)20190831(10)0019584754
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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: 08/31/2019
• Device Model Number: H74939293076030
• Device Catalogue Number: 39293-07603
• Device Lot Number: 0019584754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR