MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-07-03 for X-REIDY BREAST LESION LOCALIZATION NEEDLE DXRBL-19.5-5.0-S manufactured by Cook, Inc..
[3571623]
Localization wire was placed by radiologist and surgeon removing wire, wire snapped leaving small distal portion in patient's breast. As per complaint form: "the surgeon informed the radiologist that the breast lesion localization needle snapped on attempted removal, between the normal and distal thin portion. There was some pushing and pulling. The 'x' of the remaining wire was left in situ. The physician said that this is the second time in six months that a wire snapped at this position and has queried a faulty batch. On the previous occasion the 'x' being correctly sited was removed with the specimen. This part of the 'x' was not sited in the lesion but in normal tissue so has remained in site. " the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[10903492]
(b)(4). No product was returned to assist in this investigation. A review of complaint history, a review of instructions for use, a review of quality control, and a review of trends were conducted during the investigation. Without the complaint product a definitive root cause cannot be determined. The event description states that "there was some pushing and pulling" this could have damaged the hook wire causing it to break upon the attempt to remove. There is insufficient evidence for root cause determination. We will continue to monitor for similar complaints. There is insufficient risk per quality engineering risk assessment to warrant risk reduction activities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00259 |
| MDR Report Key | 3216939 |
| Report Source | 01,08 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-06-05 |
| Date of Event | 2013-06-04 |
| Date Facility Aware | 2013-06-04 |
| Report Date | 2013-06-05 |
| Date Mfgr Received | 2013-06-05 |
| Device Manufacturer Date | 2011-08-11 |
| Date Added to Maude | 2013-07-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-REIDY BREAST LESION LOCALIZATION NEEDLE |
| Product Code | DWO |
| Date Received | 2013-07-03 |
| Model Number | NA |
| Catalog Number | DXRBL-19.5-5.0-S |
| Lot Number | 2791383 |
| ID Number | NA |
| Device Expiration Date | 2016-07-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 34 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-03 |