MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS GM11009520 INTERSTITIAL NEEDLES

Model Number GM11009520

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Patient prostate was treated with brachytherapy using 17g stainless steel interstitial needle 250mm, part (b)(4).During the insertion of the first needle, the physician decided to change the position of the needle and found it difficult to move.The physician removed the needle from the prostate.The physician noted, after removal of the needle from the patient, that the trocar tip was missing.The physician did not re-implant this needle.Hdr treatment proceeded with implant of 17 needles.After completion of treatment the needles were removed.The nurse cleaning the needles observed 3 of them had missing trocar tips.2 tips were found in the cleaning tray.2 needle tips were determined to be lodged in the treated prostate.All 4 missing tips have been accounted for.The site consulted with urologist and decided to leave the 2 needle tips in the prostate to be used as fiducial markers.Site had previously planned to insert fiducial markers into the prostate in conjunction with the patient¿s treatment.The tips are not radioactive.The patient received extended anesthesia during the consultation with the urologist.The site has confirmed there were no complications from the extended anesthesia.The investigation is ongoing and therefore as a precautionary measure, varian has placed a stop order prohibiting shipment.All product within varian control has been quarantined.A review of varian records indicates there have been no prior reports of injury from this product.Varian will file the final report once the investigation is completed. .

Manufacturer Narrative

Root cause: manufacturing; the cause for the tip breakage lies in inconsistent manufacturing process of buffing which diminishes the wall thickness at the needle tip and welding seam.This inconsistent manufacturing process led to erosion of the needle tip weld.Any lateral force on the tip will cause the weld to fracture and the tip to detach.Product labeling does contain sufficient inspection criteria to detect a detached needle tip as damage.The ifu warns to not further use a broken or damaged needle varian has initiated a field action for this issue.All further information will be reported under 21 cfr 806.Issue was reported via 806.10, report # 2916710-07/11/2019-001r.Varian has determined the issue involving stainless steel needle tips breaking does not meet reportability criteria and will not be reported for future incidents.Recurrence of the issue would not likely result in serious harm.

Event Description

Reference mw-2019-00004 mfr# 1124791-2019-00001.

• Brand Name: GM11009520 INTERSTITIAL NEEDLES
• Type of Device: GM11009520 INTERSTITIAL NEEDLES
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 501 locust ave #1; charlottesville VA 22902
• MDR Report Key: 8722013
• MDR Text Key: 166753054
• Report Number: 1124791-2019-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• PMA/PMN Number: K160815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GM11009520
• Device Catalogue Number: GM11009520
• Device Lot Number: R43,S46,T11,T15,T28,T39T48,U13
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2916710-07/11/2019-001R
• Patient Sequence Number: 1
• Patient Outcome(s): Other