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

Catalog Number	AB35W06100080
Medical Device Problem Codes	Burst Container or Vessel (1074); 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	03/21/2019
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
The physician was attempting to use an evercross balloon to treat an av fistula.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped with per ifu with no issues.Six inflations were performed.It was reported that during balloon inflation to 18atm the balloon burst.During removal of the device from the patient, the distal marker detached from the device and remained in the patient.The balloon was removed from the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: no attempts were or will be made to remove the detached portion.The patient is safe and experiencing no adverse effects due to this.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: 8455172
• Report Number: 2183870-2019-00148
• Device Sequence Number: 2926863
• Product Code: LIT
• UDI-Device Identifier: 00821684061688
• UDI-Public: 00821684061688
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 07/22/2019

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: 08/02/2021
• Device Catalogue Number: AB35W06100080
• Device Lot Number: A686613
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/27/2019; 07/19/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/12/2019; 07/22/2019
• 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