ARROW-KARLAN INTRODUCER CS-01700 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-07 for ARROW-KARLAN INTRODUCER CS-01700 * manufactured by Arrow International Inc..

Event Text Entries

[21253429] A laparoscopic cholangiography set was opened for use in the case. When the nurse attempted to fill the balloon on the device, it was unable to hold pressure. A second set was opened and again they attempted to inflate the balloon but because of a leak were unable to do so. A third set was opened and inflation attempted. This time it was successful. The procedure was then completed without any further complications.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 756748
• MDR Report Key: 756748
• Date Received: 2006-08-07
• Date of Report: 2006-08-03
• Date of Event: 2006-07-01
• Report Date: 2006-08-03
• Date Reported to FDA: 2006-08-07
• Date Added to Maude: 2006-09-05
• 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: 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 Sequence Number: 1

• Brand Name: ARROW-KARLAN INTRODUCER
• Generic Name: LAPAROSCOPIC CHOLANGIOGRAPHY SET
• Product Code: GCJ
• Date Received: 2006-08-07
• Model Number: CS-01700
• Catalog Number: *
• Lot Number: MF6036705
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: 16 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 744638
• Manufacturer: ARROW INTERNATIONAL INC.
• Manufacturer Address: 2400 BERNVILLE RD. READING PA 19605 US

Device Sequence Number: 2

• Brand Name: ARROW-KARLAN INTRODUCER
• Generic Name: LAPAROSCOPIC CHOLANGIOGRAPHY SET
• Product Code: CGJ
• Date Received: 2006-08-07
• Model Number: *
• Catalog Number: *
• Lot Number: MF5124826
• ID Number: *
• Device Age: 16 MO.
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 744639
• Manufacturer: ARROW INTERNATIONAL INC.
• Manufacturer Address: 2400 BERNVILLE RD. READING PA 19605 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-08-07