MAUDE Adverse Event Report: ELEKTA, INC. PROGUIDE; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number 189616-01

Device Problems Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem Pain (1994)

Event Date 10/09/2015

Event Type  malfunction  

Event Description

The treatment itself involves a check by the treatment machine to confirm appropriate integrity of the catheters.After the treatment was completed, when staff was re-inserting the metal stylet back into the needle, staff noticed some resistance to insertion of stylet in the needle #17, which was more than the usual.This was anticipated to some extent due to the anterior location of the needle and the deflection from the pubic symphysis that was noted on the ct scans from pre-treatment.To prevent this from happening from changes in patient position over the duration of treatment, the metal stylets are re-inserted back into the plastic catheters at the end of each treatment to provide internal support.Should there be a bend/tightening, gentle push is provided to the stylet to circumvent the area of narrowing.In this case, more than usual effort was noticed on re-insertion of the stylet.As staff attempted this, a sudden give-way was noticed which was accompanied by patient noticing some pain.On withdrawal of the stylet, there was some blood noticed inside the catheter lumen.Concerned about the loss of integrity of the wall of the plastic catheter, in consultation with the medical physics faculty and drs, the staff decided not to use that catheter for the remaining treatments.A partially inserted metal stylet till the point of obstruction was left in place in the needle #17 for the remainder of this course and removed only at the time of ct scans performed over the next two days (to avoid metal artifact on the images).Treatment otherwise was completed without any other complications.A ct scan identified a small collection in the pelvic cavity, noted above the vaginal cuff and posterior to the bladder.This collection was not seen on the baseline ct scan.It is noted that the location of this collection was separate from the location of the tip of needle #17.After treatment was completed, the implant was removed.Anticipating some difficulty with the catheter #17, this was removed very slowly as a first step before rest of the implant.This identified the broken tip of the catheter, which was severed off from the rest of the catheter.The tip did not come out with the rest of the catheter.After this, rest of the implant was removed as a single unit with anticipated amount of minimal bleeding and some discomfort to the patient.Measuring this with an intact needle, about 4.5 cm of the catheter was noted to be retained inside.Staff requested medical physics faculty to reach out to the company to get more information on the material of the catheter and it's biocompatibility.Based on the location of the catheter and since the implant was just removed, to prevent initiation of any bleeding, staff clinically judged it safe to discharge the patient with the retained catheter tip with the plan to bring the patient back to the or in a week for an examination under anesthesia and attempt to removal of the retained catheter tip.Manufacturer response for plastic hollow catheter for interstitial implants, proguide sharp needle set (per site reporter): they are investigating with their product supply center.

• Brand Name: PROGUIDE
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): ELEKTA, INC.; 400 perimeter center terrace; suite 50; atlanta GA 30346
• MDR Report Key: 5219658
• MDR Text Key: 31017340
• Report Number: 5219658
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Expiration Date: 11/18/2018
• Device Model Number: 189616-01
• Device Catalogue Number: 189.616-01
• Device Lot Number: 133139.022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 94