HEMAFLEX PTCA SHEATH KIT N/A 010047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for HEMAFLEX PTCA SHEATH KIT N/A 010047 manufactured by Bard, Incorporated.

Event Text Entries

[10654] During catheterization procedure, a pcta arterial sheath disonnected and remained in right femorl artery. Patient taken to operating room for removal of sheath on 12/22/93.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 15419
• MDR Report Key: 15419
• Date Received: 1994-01-10
• Date of Report: 1993-12-22
• Date of Event: 1993-12-22
• Date Facility Aware: 1993-12-22
• Report Date: 1993-12-22
• Date Reported to Mfgr: 1993-12-23
• Date Added to Maude: 1994-08-23
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• 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: HEMAFLEX PTCA SHEATH KIT
• Product Code: EYT
• Date Received: 1994-01-10
• Returned To Mfg: 1993-12-22
• Model Number: N/A
• Catalog Number: 010047
• Lot Number: 09FD0177
• ID Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 15413
• Manufacturer: BARD, INCORPORATED
• Manufacturer Address: 1200 TECHNOLOGY PARK BILLERICA MA 01821 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-01-10