MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-02-07 for FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET AL13030000 manufactured by Varian Medical Systems, Inc..
[16086797]
The customer reported that a gyn patient has allegedly suffered severe radiation reactions outside the treatment area. The patient was treated with the al13030000-fletcher-suit-delclos-style applicator set (fsd) in conjunction with the (b)(4) reusable transfer guide tubes (rtgt). They stated that they checked the plans and delivery, but "didn't find any problem". The customer stated that the rtgts are in good condition and all measure within 1mm of the nominal length of 121. 4 cm (120. 0 cm for treatment planning). There is a mark on the rtgt, correlating to the table in the rtgt's instructions for use, that is used to verify the insertion depth of the rtgt in the applicator. This is checked prior to and after treatment by 3 people (physician, nurse and physicist). In addition, the customer indicated that there was no evidence that the applicators had been pushed out of the patient at any point during the treatment. The patient was treated with 3 fractions of 8gy each. The physician has concluded that the suspected treatment error occurred for only on fraction, because the patient had a full response to the radiation, and at this time he assumes there was sufficient target dose to result in disease resolution.
Patient Sequence No: 1, Text Type: D, B5
[16283043]
Varian brachytherapy personnel conducted an on-site investigation at the customer's facility. The treatment workflow, source positioning, and applicators were all discussed and evaluated. All source positioning was accurate and delivered within the afterloader as specified. From the gathered data, it can be concluded that all of the equipment being used at the hospital is within specifications and operating as expected. The on-site visit identified possible treatment workflow contributing factors but no conclusions could be verified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2014-00001 |
| MDR Report Key | 3627993 |
| Report Source | 01,05,06 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-09 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2014-01-09 |
| Date Added to Maude | 2014-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK KATTMAN |
| Manufacturer Street | 700 HARRIS STREET SUITE 109 |
| Manufacturer City | CHARLOTTESVILLE VA 22903 |
| Manufacturer Country | US |
| Manufacturer Postal | 22903 |
| Manufacturer Phone | 4349518632 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer City | CRAWLEY, WEST SUSSEX |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET |
| Generic Name | INTRACAVITARY BRACHYTHERAPY APPLICATOR |
| Product Code | JAQ |
| Date Received | 2014-02-07 |
| Catalog Number | AL13030000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3100 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-07 |