MAUDE Adverse Event Report: CORDIS (JOHNSON & JOHNSON) PTA PRO; DILATION CATHETER

Catalog Number	419-7020X
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Balloon ruptured while inflated in the lsfa.No harm to pt.

• Brand Name: PTA PRO
• Common Device Name: DILATION CATHETER
• Manufacturer (Section D): CORDIS (JOHNSON & JOHNSON); santa clara CA 95054
• MDR Report Key: 5885405
• Report Number: MW5064157
• Device Sequence Number: 11083063
• Product Code: LIT
• UDI-Device Identifier: 20705032003466
• UDI-Public: (01)20705032003466
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: No Information
• Type of Report: Initial
• Report Date (Section B): 08/15/2016

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: 06/30/2018
• Device Catalogue Number: 419-7020X
• Device Lot Number: 17293201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• 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
• Patient Age: 70 YR
• Patient Weight: 80