MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS VISTA BRITETIP GUIDING CATHETER; CATHETER, PERCUTANEOUS

Model Number 67011000

Device Problems Difficult to Insert (1316); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Event Description

Catheter inserted into patient.Md able to pass wire through catheter, but unable to pass guidliner.Md removed catheter and noticed pinched section.Md stated it was manufacturer defect.Catheter removed intact no harm to patient.

• Brand Name: CORDIS VISTA BRITETIP GUIDING CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 7471863
• MDR Text Key: 106867970
• Report Number: 7471863
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2018

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
• Device Operator: No Information
• Device Model Number: 67011000
• Device Catalogue Number: 67011000
• Device Lot Number: 17307256
• Other Device ID Number: 6FR AR1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR