CRAGG MCNAMERA * 201-0217

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-09 for CRAGG MCNAMERA * 201-0217 manufactured by Micro-therapeutics Inc..

Event Text Entries

[20760004] Two catheters were involved. The first catheter's radiopaque marker separated from the catheter and had to be extracted from the subcutaneous tissues. The second catheter's marker and plastic valve tip separated from the catheter and also had to be extracted. This occurred in the same pt during the same graft thrombolysis procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014929
• MDR Report Key: 196590
• Date Received: 1998-11-09
• Date of Report: 1998-11-09
• Date of Event: 1998-11-03
• Date Added to Maude: 1998-11-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CRAGG MCNAMERA
• Generic Name: VALVED INFUSION CATHETER
• Product Code: JCY
• Date Received: 1998-11-09
• Returned To Mfg: 1998-11-05
• Model Number: *
• Catalog Number: 201-0217
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 190996
• Manufacturer: MICRO-THERAPEUTICS INC.
• Manufacturer Address: 1062-F CALLE NAYOCIO SAN CLEMENTE CA 92673 US

Device Sequence Number: 2

• Brand Name: CRAGG MCNAMERA
• Generic Name: VALVED INFUSION CATHETER
• Product Code: JCY
• Date Received: 1998-11-09
• Returned To Mfg: 1998-11-05
• Model Number: *
• Catalog Number: 201-0217
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 191000
• Manufacturer: MICRO-THERAPEUTICS INC.
• Manufacturer Address: 1062-F CALLE NAYOCIO SAN CLEMENTE CA 92673 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-11-09