MAUDE Adverse Event Report: MEDTRONIC, INC. PROTE´GE´¿ EVERFLEX¿; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PRB35-05-080-120
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient in cath lab for right superficial femoral artery (sfa) leg intervention.Total occlusion crossed with wire, atherectomy performed and balloon inflation completed.Decision to insert self-deployment stent.Stent advanced without difficulty and self-deployment completed.Delivery catheter withdrawn and noticed to be missing by scrub tech.Angiogram shows foreign body at profunda artery proximal to deployed stent.Attempts to snare foreign body unsuccessful.Angiogram shows foreign body in lateral branch off of profunda.

• Brand Name: PROTE´GE´¿ EVERFLEX¿
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 narthan lane north; plymouth MN 55442
• MDR Report Key: 7669343
• Report Number: 7669343
• Device Sequence Number: 920307
• Product Code: FGE
• UDI-Device Identifier: 00821684068588
• UDI-Public: (01)00821684068588
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2018
• Report Date (Section F): 06/20/2018

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 Model Number: PRB35-05-080-120
• Device Catalogue Number: PRB35-05-080-120
• Device Lot Number: A526244
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 06/20/2018