MAUDE Adverse Event Report: ISORAY MEDICAL, INC. / SHANNON GOLDENSTEIN PROXCELAN MODEL CS-1; CS-1 CESIUM-131 BRACHYTHERAPY SEEDS

Model Number CS-1

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Manufacturer representative observed this case, wherein 9 individual isoray cesium-131 sources ("seeds") were implanted into a vulvar tumor.This representative reports that rather than the customary 1.0 cm spacing of sources implanted into the tumor, the physician placed the sources at 0.5 cm apart.Manufacturer believes that the placing of sources closer together than 1.0 cm may have caused excessive radiation dose to be deposited, thereby possibly contributing to this adverse event.Additionally, prior to the cesium-131 seed implant this patient underwent a course of external beam radiation therapy, which on its own or in combination with the cesium-131 seed implant may have contributed to this adverse event.Manufacturer has made multiple attempts to contact the physician involved in this case in order to obtain more specifics, however no reply has been received.

Event Description

During a customer service follow-up with the facility, 22 days post implant, isoray was notified that the patient "got proctitis and a colorectal surgeon diverted her with a colostomy." while clarifying if the issue had connection to the implant, the facility suggested that the temporal course of the complication suggests that the implant was associated with the development of the adverse event.

• Brand Name: PROXCELAN MODEL CS-1
• Type of Device: CS-1 CESIUM-131 BRACHYTHERAPY SEEDS
• Manufacturer (Section D): ISORAY MEDICAL, INC. / SHANNON GOLDENSTEIN; 350 hills street, ste., 106; richland, wa WA 99354
• Manufacturer Contact: shannon goldenstein ; 350 hills street., suite., 106; richland, WA 99354 ; 5093751202
• MDR Report Key: 9284730
• MDR Text Key: 165261202
• Report Number: 3005520039-2019-00001
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: M748CS10
• UDI-Public: M748CS10
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2019
• Device Model Number: CS-1
• Device Catalogue Number: N/A
• Device Lot Number: DO1935-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR