E-Z GLIDER STRAIGHT TIP .035" GW 5/BX 35BX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-20 for E-Z GLIDER STRAIGHT TIP .035" GW 5/BX 35BX manufactured by Acmi Corporation.

Event Text Entries

[250195] Tip of guide wire came off when the feeding tip was taken off. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2124979-2002-00075
• MDR Report Key: 412598
• Date Received: 2002-08-20
• Date of Report: 2002-08-15
• Date of Event: 2002-07-03
• Date Facility Aware: 2002-07-03
• Date Mfgr Received: 2002-07-03
• Date Added to Maude: 2002-08-27
• 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: 3
• Manufacturer Contact: DON KEREN
• Manufacturer Street: 136 TURNPIKE ROAD
• Manufacturer City: SOUTHBOROUGH MA 01772
• Manufacturer Country: US
• Manufacturer Postal: 01772
• Manufacturer Phone: 5088042708
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: E-Z GLIDER STRAIGHT TIP .035" GW 5/BX
• Generic Name: GUIDEWIRE
• Product Code: EYA
• Date Received: 2002-08-20
• Model Number: 35BX
• Catalog Number: 35BX
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 401653
• Manufacturer: ACMI CORPORATION
• Manufacturer Address: 3037 MT. PLEASANT ST. RACINE WI 53404 US
• Baseline Brand Name: E-Z GLIDER GUIDEWIRE
• Baseline Generic Name: URETERAL GUIDEWIRE
• Baseline Catalog No: 35BX
• Baseline ID: .035", 150CM, S
• Baseline Device Family: HYDROPHILIC COATED GUIDEWIRE
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 60
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-08-20