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 2013-12-17 for SHIELDED RECTAL APPLICATOR SET AL13129005 manufactured by Varian Medical Systems, Inc..
[4126248]
The customer reported that in the last 2 years, they had 3 cases (out of hundreds) of pts developing radiation reactions in the source path prior to the treatment area. They stated that they checked the plans and delivery, but "didn't find any problem". One pt was treated using the al13129005 shielded rectal applicator in conjunction with the al07292001/al07292002/al07292003 reusable transfer guide tubes (tgt). The customer stated that the tgts are in good condition and all measure within 1mm of the nominal length of 121. 4 cm (120. 0 cm for treatment planning). This is a mark on the tgt, correlating to the table in the tgt's instructions for use, that is used to verify the insertion depth of the tgt in the applicator. This is checked prior to the treatment by three people (physician, nurse, and physicist) as well as after the treatment. In addition, the customer indicated that there was no evidence that the applicators had been pushed out of the pts at any point during the treatments. All pts had a full tumor response, so there was no indication to that there was an under-dose from a pt outcome perspective. Details on other 2 incidents filed under mfr report #9612638-2013-00014 and #9612638-2013-00016.
Patient Sequence No: 1, Text Type: D, B5
[11478019]
Additional information: catalog # al07292002, al07292003. This issue remain under investigation. Additional information has been requested from the customer. A follow-up report will be filed once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612638-2013-00015 |
| MDR Report Key | 3541694 |
| Report Source | 01,05,06 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-11-17 |
| Date of Event | 2013-11-17 |
| Date Mfgr Received | 2013-11-17 |
| Date Added to Maude | 2014-01-16 |
| 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 KATTMANN, DIRECTOR |
| 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 HAAN GMBH |
| Manufacturer Street | BERGISCHE STRASSE 16 |
| Manufacturer City | HAAN 42781 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 42781 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIELDED RECTAL APPLICATOR SET |
| Generic Name | BRACHYTHERAPY APPLICATOR |
| Product Code | JAQ |
| Date Received | 2013-12-17 |
| Catalog Number | AL13129005 |
| ID Number | AL07292001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-12-17 |