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

Catalog Number	AB35W08060135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use an evercross balloon to treat a lesion in the mid iliac artery ¿ common with moderate tortuosity and severe calcification 60% stenosis in a patient.No damage noted to packaging, i.E.Shelf carton, hoop/tray, no issues noted when removing the device from the hoop/tray, device was prepped per the ifu with no issues noted.It was reported that device or component detached, cracked, or fractured during delivery through the vessel at the balloon.A detached portioned of the balloon remained in the patient which was stented in place.The device did not pass through a previously-deployed stent, resistance was encountered when advancing the device, excessive force was not used.No further patient injury reported for this event.
Additional Manufacturer Narrative
Additional information: component embolization occurred post inflation during withdrawal if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8403089
• Report Number: 2183870-2019-00121
• Device Sequence Number: 2326762
• Product Code: LIT
• UDI-Device Identifier: 00821684062081
• UDI-Public: 00821684062081
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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: 11/13/2021
• Device Catalogue Number: AB35W08060135
• Device Lot Number: A740004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 06/17/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/26/2019; 06/20/2019
• 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