ARROW 7 FRENCH DOUBLE LUMEN 16CM CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for ARROW 7 FRENCH DOUBLE LUMEN 16CM CATHETER manufactured by Arrow International, Inc..

Event Text Entries

[2989] Patient believed to have suffered blood vessel injury during a procedure where a catheter was being changed using a guidewire. During this procedure, the guidewire apparently exited through a round accessory opening approximately 2. 5cm from the distal end of the catheter. Arrow informs us that they are remanufacturing the catheter to prevent further incidentsinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4549
• MDR Report Key: 4549
• Date Received: 1992-07-31
• Date of Report: 1992-07-30
• Date of Event: 1992-04-29
• Report Date: 1992-07-30
• Date Added to Maude: 1993-05-27
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARROW 7 FRENCH DOUBLE LUMEN 16CM CATHETER
• Product Code: FGH
• Date Received: 1992-07-31
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4268
• Manufacturer: ARROW INTERNATIONAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-31