HYPERTHERMIA CATHETER VHOC VHOC8L7H1557R2.5D30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-10 for HYPERTHERMIA CATHETER VHOC VHOC8L7H1557R2.5D30 manufactured by Cook, Inc..

Event Text Entries

[15378764] Upon removal of a template containing hyperthermia catheters, brachytherapy needles and combination hyperthermia/brachytherapy catheters, a portion of one of the hyperthermia/brachytherapy catheters separated and remained in the perineal region of the pt. All iridium-192 brachytherapy sources used in the hyperthermia/brachytherapy catheters had been recovered and shielded prior to the template removal. The remaining iridium-192 sources in the brachythyerapy needles were recovered from the template in the source lab. Subsequently, the broken catheter was noticed while the template was being rinsed, prior to the catheters being disengaged. A radiation oncologist was notified immediately and he ordered a radiograph to verify that a piece of the catheter was still within the pt and to determine its location. He attempted to extract the catheter remnant by pulling on exposed wire filaments protruding from the perineal skin but was unsuccessful. The pt's surgeon was notified and he arranged to remove the catheter remnant 3 days later on 10/3. The procedure involved the removal of fatty tissue containing the catheter remnant from a depth of approx 3 cm, through a small perineal incision.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1003977
• MDR Report Key: 17560
• Date Received: 1994-11-10
• Date of Report: 1994-10-24
• Date of Event: 1994-09-30
• Date Added to Maude: 1994-11-14
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HYPERTHERMIA CATHETER
• Generic Name: HYPERTHERMIA CATHETER
• Product Code: LMZ
• Date Received: 1994-11-10
• Model Number: VHOC
• Catalog Number: VHOC8L7H1557R2.5D30
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 17481
• Manufacturer: COOK, INC.
• Manufacturer Address: BLOOMINGTON IN 47402 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-11-10