CASTANEDA OVER THE-WIRE BRUSH 202-0107/202-0105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-11-10 for CASTANEDA OVER THE-WIRE BRUSH 202-0107/202-0105 manufactured by Micro Therapeutics, Inc..

Event Text Entries

[16037330] Used device on dialysis graft using cross-over technique. Completed both arterial and venous sides of graft when physician noted, on fluoroscopy, that piece from brush had broken off and was on guidewire.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2029214-1998-00003
• MDR Report Key: 197706
• Report Source: 07
• Date Received: 1998-11-10
• Date of Report: 1998-11-10
• Date of Event: 1998-10-14
• Date Mfgr Received: 1998-10-16
• Device Manufacturer Date: 1998-08-01
• Date Added to Maude: 1998-11-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CASTANEDA OVER THE-WIRE BRUSH
• Generic Name: THROMBOLYTIC BRUSH CATHETER AND MOTOR DRIVE
• Product Code: JCY
• Date Received: 1998-11-10
• Returned To Mfg: 1998-10-16
• Model Number: 202-0107/202-0105
• Catalog Number: 202-0107/202-0105
• Lot Number: M980474/M980410
• ID Number: *
• Device Expiration Date: 1999-02-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 192080
• Manufacturer: MICRO THERAPEUTICS, INC.
• Manufacturer Address: 1062-F CALLE NEGOCIO SAN CLEMENTE CA 92673 US
• Baseline Brand Name: CASTANEDA OVER THE-WIRE BRUSH
• Baseline Generic Name: THROMBOLYTIC BRUSH CATHETER AND MOTOR DRIVE
• Baseline Model No: 202-0107/202-01
• Baseline Catalog No: 202-0107/202-0105
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-11-10