MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	AB35W08080080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician intended to use an evercross balloon catheter during procedure for treatment of the com/external iliac.The lesion was calcified.It is reported that the patient underwent coronary angiography.The patient was treated with self expanded stent and the evercross balloon was then used.During procedure, it is reported that the balloon detached and lodged in the distal aorta, at the left iliac artery.The patient required surgery for extraction of the balloon.It is reported that staff are not sure how the balloon detached.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6192987
• Report Number: 2183870-2016-00743
• Device Sequence Number: 589251
• Product Code: LIT
• UDI-Device Identifier: 00821684062098
• UDI-Public: 00821684062098
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2019
• Device Model Number: AB35W08080080
• Device Lot Number: A232691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/21/2016
• 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: Required Intervention