MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-11-03 for X-REIDY BREAST LESION LOCALIZATION NEEDLE N/A DXRBL-18-9.0 manufactured by Cook Inc.
[59046676]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59046677]
It was reported during a procedure that one of the x-reidy breast localization wires broke off in the patient's breast. A mammography revealed approximately at 12mm tip of the wire retained in the patient's breast. Reportedly the surgeon will attempt retrieval after discussing with the patient. No other information was available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[66689477]
Mij needle, tumor localization. Investigation results - clinical assessment: summary of the event: it was reported that "patient went to theatre about 2 weeks ago with 2 wires. The cancer has been safely excised with clear margins however during the operation one of the wires broke. This has resulted in the tip of the wire (approx. 12mm on mammography) being retained in the breast. 2mm tip of wire. Surgeon to attempt retrieval after discussion with patient ( yet to take place)". It was also reported that "a section of the device remained inside the patient? S body. 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". Clinical opinion of the event: based on the limited available information it is not clear if the leading cause to this event might be associated with a preexisting patient condition, the medical procedure or an eventual malfunction of the device. A request for more information and images was sent. This clinical review will be reassessed if more information will become available. A review of the device history record, documentation, drawings, manufacturing instructions, quality controls were conducted, as well as a visual inspection of the device in question. Manufacturing instructions discuss recommended techniques for grinding and shaping product. Refer to quality control specifications inspect all sections 100%, unless otherwise specified. Verify outside diameter and length of wire guide and hook. Inspection method: level i, measure outside diameter with micrometer or calipers. 100% measure length with meter scale. Verify distance between distal solder joint and proximal? Legs?. Inspection method: measure with magnifying eyepiece. Verify solder joint is smooth, secure and has sufficient solder flow at distal end of wire guide and twist of dxr. Inspection method: slightly tug and feel solder joint. Visually examine with at least 7x magnification, must be free of cracks, sharpness and excessive buildup. Verify? Legs? Of dxr are free of foreign matter (discoloration from heat is acceptable). Inspection method: visually examine. Verify weld joint at proximal end of wire guide is smooth and mandrill wire is caught securely. Inspection method: slightly tug and feel weld joint, must be round and smooth. Coil should remain taut and not springy. Verify coil is clean and smooth without damage, outstanding coils or kinks. Inspection method: level i, visually examine and feel. Verify? Legs? Of dxr are as specified and not bent. Inspection method: visually examine. Verify? Legs? Of dxr are ground with oval bevels, facing outward from center of hook, free of burrs, nicks and grinding marks. Inspection method: visually examine with magnifying eyepiece and feel. 4. 10 verify cut leg does not protrude beyond outside diameter of twist and does not have excessive burrs. Inspection method: visually examine with magnifying eyepiece and feel. Verify? Legs? Of dxr are specified distance apart. Inspection method: visually examine. Measure with meter scale. Device failure analysis: a search of the design history file found 1 nonconformance for "434 - foreign matter" ; this is unrelated to the failure mode. There are no other complaints from this lot. The device was returned on 10nov2016 and 22nov2016. A detached portion of the wire with 'x' hook (dxr) attached was returned in used condition. It was covered in bio matter. The length of the dxr hook was in spec. The distance between the separated wires proximal end to the x-hook's proximal leg was 2mm. This coincides with the location of the junction with the cannula, per manufacturer's drawing. Thus, the x-hook broke at this junction. The junction is soldered per manufacturing instructions in quality control. Based on the location of the break, it is feasible to suggest that insufficient soldering, or manipulation/bending of the device at the junction, caused the hook section to separate. However, without more information a root cause cannot be determined between the two. There is no evidence to suggest that the device was not manufactured according to specification. Per risk assessment, no further risk reduction is required at this time. We will continue to monitor for similar complaints, and have notified the appropriate personnel of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-01259 |
| MDR Report Key | 6075646 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-07 |
| Date Mfgr Received | 2016-11-10 |
| Device Manufacturer Date | 2016-03-11 |
| Date Added to Maude | 2016-11-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RITA HARDEN |
| 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 |
| Generic Name | MIJ NEEDLE, TUMOR LOCALIZATION |
| Product Code | MIJ |
| Date Received | 2016-11-03 |
| Model Number | N/A |
| Catalog Number | DXRBL-18-9.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-03 |