PERITONEAL CATHETER STRAIGHT VENTRICULAR CATHETER AND HAKIM REF 82-3162 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-01 for PERITONEAL CATHETER STRAIGHT VENTRICULAR CATHETER AND HAKIM REF 82-3162 * manufactured by Codman Shurtleff.

Event Text Entries

[390323] This patient had a significant fall a few years ago. At the time of the fall, the patient had a frontal floor contusion, developed anosmia and cognitive difficulties. Additionally, they had bilateral occipital epidural hematomas requirng surgical decompression. The patient then had a shunt and cranioplasty performed, which worked quite well until at some point they developed a fluid collection in their abdomen, which was worked up with ct scans. The scans revealed that the patient had distal shunt failure. 2 to 3 days prior to this surgery, the patient developed swelling in the head and around the shunt tubing. A ct scan was urgently performed and it revealed that the patient had a porencephalic cyst and mass effect with shift from right to left. The patient was taken straight from the ct scanner to the operating room. The physician reported that there was a separation between the valve and tube. It was reported taht the device was cleaned and given to the codman representative.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 616493
• MDR Report Key: 616493
• Date Received: 2005-06-01
• Date of Report: 2005-05-26
• Date of Event: 2005-05-13
• Report Date: 2005-05-26
• Date Reported to FDA: 2005-06-01
• Date Added to Maude: 2005-06-24
• 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 Sequence Number: 1

• Brand Name: PERITONEAL CATHETER STRAIGHT VENTRICULAR CATHETER AND HAKIM
• Generic Name: VENTRICULAR PERITONEAL SHUNT
• Product Code: JXG
• Date Received: 2005-06-01
• Model Number: REF 82-3162
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 3 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 606228
• Manufacturer: CODMAN SHURTLEFF
• Manufacturer Address: 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: PERITONEAL CATHETER
• Product Code: FJS
• Date Received: 2005-06-01
• Model Number: *
• Catalog Number: *
• Lot Number: 1156015
• ID Number: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 606229
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 3

• Brand Name: *
• Generic Name: STRAIGHT CATHETER
• Product Code: FKO
• Date Received: 2005-06-01
• Model Number: *
• Catalog Number: *
• Lot Number: 821776
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 606230
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2005-06-01