INTUSSUSCEPTION AIR REDUCTION KIT WITH PINK TIP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-06 for INTUSSUSCEPTION AIR REDUCTION KIT WITH PINK TIP * manufactured by Gri Medical Products, Inc.

Event Text Entries

[311172] Add'l info rec'd from mfr 8/31/2004: gri does not manufacture device #3. A copy of the report has been forwarded to that company. The iark-2 used in this case was from a lot #081001. It was manufactured by company's previous ma location, and was not sold to the reporting facility. The device was disposed. No evaluation of the actual device is possible. The autopsy report is not yet available. It cannot be reliably determined if the device contributed to the death as no allegations or data exist of the device malfuncitoning. Bowel perforation is a consequence of this procedure that is fully documented in the literature and instructions for use. No other incidences have been reported to date. Mfr will continue to monitor and investigate this incident as info becomes available. The catheter / tip used in these procedures is determined by the radiologist based on the size of the pt. We are aware of other institutions using foley type catheters for smaller pts. The pt prior to the procedure had a 3 day history of symptoms and complaints before presenting to the reporting facility.
Patient Sequence No: 1, Text Type: D, B5

[17827977] The pt was being treated for an intussusception in the radiology suite. The physician used air reduction kit and 22 inch french foley catheter instead of catheter that came with air reduction kit for procedure due to age of pt. The pt had foley catheter inserted into rectum and 8cc of air instilled into the foley balloon. Under fluoroscopic control, an attempt at air reduction was made using 120 mmhg of pressure. The intussusception was slowly reduced. Suddenly, pt arrested. Perforation noted and heart stopped. Pt coded and expired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 537760
• MDR Report Key: 537760
• Date Received: 2004-08-06
• Date of Report: 2004-08-03
• Date of Event: 2004-07-26
• Report Date: 2004-07-30
• Date Reported to FDA: 2004-08-03
• Date Added to Maude: 2004-08-06
• 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: 3
• 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: INTUSSUSCEPTION AIR REDUCTION KIT WITH PINK TIP
• Generic Name: AIR REDUCTION
• Product Code: KDH
• Date Received: 2004-08-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: PRODUCT NO. IARK-2
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 527013
• Manufacturer: GRI MEDICAL PRODUCTS, INC
• Manufacturer Address: 4937 EAST RED RANGE WAY CAVE CREEK AZ 85331 US

Device Sequence Number: 2

• Brand Name: BARDEX IC
• Generic Name: 22 INCH FRENCH 5 CC RIBBED BALLOON
• Product Code: KOD
• Date Received: 2004-08-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: PRODUCT NO. IARK-2
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 535860
• Manufacturer: C. R. BARD, INC
• Manufacturer Address: 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US

Device Sequence Number: 3

• Brand Name: IARB BULB WITH GAUGE
• Generic Name: PRESSURE UNIT
• Product Code: KQT
• Date Received: 2004-08-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: 5098-03, 7W-1065-M
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 535863
• Manufacturer: GRI MEDICAL PRODUCTS, INC.
• Manufacturer Address: 4937 EAST RED RANGE WAY CAVE CREEK AZ 85331 US

Device Sequence Number: 4

• Brand Name: KENDALL ARGYLE 5 IN 1 CONNECTOR
• Generic Name: CONNECTOR FOR TUBING
• Product Code: BZA
• Date Received: 2004-08-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 534979
• Manufacturer: KENDALL, A DIV OF TYCO HEALTHCARE GROUP
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-08-06