MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP; CARDIAC CATHETER

Catalog Number 67005200

Device Problems Partial Blockage (1065); Device Damaged Prior to Use (2284); Defective Device (2588); Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2015

Event Type  malfunction  

Event Description

The guiding catheter was defective out of the package.The catheter was sealed shut along the shaft.It appears to have been pinched closed at the distal end of the catheter creating a flattened area.

• Brand Name: VISTA BRITE TIP
• Type of Device: CARDIAC CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 6500 paseo padre parkway; fremont CA 94555
• MDR Report Key: 5010323
• MDR Text Key: 23255339
• Report Number: 5010323
• 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: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 67005200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 102