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

Model Number	26926
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 08dec2021.A 6mm x 150mm x 130cm innova self-expanding stent was selected for use in a stenting procedure within the superficial femoral artery.Upon opening the package, the tip of the catheter looked defective.Another of the same device was used to complete the procedure.No patient complications were reported.However, device analysis revealed partial deployment of the stent.
Additional Manufacturer Narrative
Device eval by manufacturer: the innova device was returned to boston scientific for analysis.The outer sheath, tip, and the remainder of the device were checked for damage.The catheter shaft showed no damage.The yellow thumbwheel lock was attached to the handle when returned; however, it was not attached in the correct rotation.The blue pull handle was partially pulled approximately 1cm from the handle body.The stent was partially deployed approximately 0.5cm.Inspection of the remainder of the device, apart from the observed issue, revealed no other issues or irregularities.The complaint was confirmed for partially deployed stent.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13087652
• Report Number: 2134265-2021-16190
• Device Sequence Number: 5926043
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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: 11/16/2025
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0026374314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown