MAUDE Adverse Event Report: EV3 INC. / COVIDIEN EVERCROSS PTA DILATATION CATHETER

Model Number	6MM X 135CM
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure, balloon on device ruptured.

• Brand Name: EVERCROSS PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): EV3 INC. / COVIDIEN ; 4600 nathan lane north; plymouth MN 55442 2920
• MDR Report Key: 6581400
• Report Number: MW5069910
• Device Sequence Number: 10785844
• Product Code: DQY
• UDI-Device Identifier: 00821684061725
• UDI-Public: (01)00821684061725
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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: 03/23/2019
• Device Model Number: 6MM X 135CM
• Device Catalogue Number: AB35W06120135
• Device Lot Number: A248122
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 108