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

Catalog Number	AB35W07080080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
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 an evercross device.No embolic protection was used.The device was prepped with no issues.It was reported that a balloon burst occurred during balloon inflation at nominal pressure while using an inflation device with hep and saline.All fragments of the balloon were retrieved.The device did not pass through a previously deployed stent, no resistance was encountered while advancing the device and no excessive force was used.The balloon was removed and two more evercross devices were used.It was reported that a balloon burst occurred with both of these devices during inflation at nominal pressure and both balloons removed from the patient.A fourth evercross was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
It has been confirmed this device was used in a separate procedure.One device, not three, were used in this procedure 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: 8292240
• Report Number: 2183870-2019-00050
• Device Sequence Number: 19229422
• Product Code: LIT
• UDI-Device Identifier: 00821684061886
• UDI-Public: 00821684061886
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/04/2019

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: 08/20/2021
• Device Catalogue Number: AB35W07080080
• Device Lot Number: A695514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1