MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26928
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile packaging was compromised.An innova stent was selected for use for a procedure.During preparation, a 1 to 2 cm hole was observed in part of the sterile packaging.The procedure was completed with another innova stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: visual analysis revealed of the returned device revealed the seal on the shelf box was open.The device pouch was still sealed and there was a visible tear on the back of the pouch, approximately 6mm wide and 7mm long.The tear appears to have been caused by something puncturing it.There was nothing loose inside the pouch and tactile test of the entire back did not reveal any abnormalities that could have potentially punctured the pouch.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the sterile packaging was compromised.An innova stent was selected for use for a procedure.During preparation, a 1 to 2 cm hole was observed in part of the sterile packaging.The procedure was completed with another innova stent.There were no patient complications reported.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8210325
• Report Number: 2134265-2018-64613
• Device Sequence Number: 13522133
• Product Code: NIP
• UDI-Device Identifier: 08714729873662
• UDI-Public: 08714729873662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 11/20/2020
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0021407715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1