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

Model Number	AB35W08020080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use two evercross 0.35 pta balloons.It was reported the balloons burst.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the 2 evercross 0.35 balloons to treat an in-stent stenosis in the iliac artery with mild tortuosity as per ifu.The lesion was calcified with 95% stenosis.The balloons passed through a previously deployed stent.It was reported the 2 balloons burst at low atmosphere, the type of balloon burst is unknown.The complete balloon was removed from the patient with no issues noted.The procedure was completed with another device.The patient is reported to be doing well.

• 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: 6730551
• Report Number: 2183870-2017-00311
• Device Sequence Number: 725523
• Product Code: LIT
• UDI-Device Identifier: 00821684061992
• UDI-Public: 00821684061992
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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: 05/08/2020
• Device Model Number: AB35W08020080
• Device Lot Number: A456848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1