MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-08 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-9.0-A manufactured by Cook Inc.
[116480633]
Pma/510(k) #: preamendment. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[116480634]
It was reported between the time a kopans modified breast lesion localization needle was placed and the scheduled procedure, the marker moved. Due to the lesion not clearly identified, resection was "irradical" and the scheduled intraoperative radiation therapy (iort) led to a re-operation. Translation of further information indicated: "small tumor mass recognizable by a small calcification mark, patient had a large commuting mom and a lot of fat and a small tumor, ingredients for dislocation. The wire is placed with the tip through the mass, but the barb still hangs in the greasy tissue: m. I. Then more likely dislocation in this single barb. We almost always place under ultrasound guide, where the tip of the needle is placed just 1-5 mm through the mass and then under echo view the wire is held in place while the needle is retracted. When masking the wire, after mammographically documenting correct position cc and lm, the thread is rolled up externally loosely and taped off with fixomul, in patients with skin that is suitable for this, not quick wounds or rashes in plasters with transparent plastic ( 'second skin', product name escaped me). Localizations take place at the end of the afternoon, patients go to the hospital for a night and are operated on during the next day. " the radiologist further reported "this was really an unfortunate coincidence, namely big, fat, commuting mamma, little tumor, unfamiliarity with this temporary thread that is less easily attached to the tumor than the x-reidy, which we all know for decades and which never really come shallower or deeper to lie after placing through a 4-double barb. An additional problem with the patient was that the x-specimen was unjustly assessed as 'successful excision', as a result of which iort continued and only after the pa of the resection sample showed that an incomplete excision had been done and the patient ultimately had to have an ablation: after iort there is no way back to sparing treatment. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02270 |
| MDR Report Key | 7764652 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-07-16 |
| Date Mfgr Received | 2018-10-01 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2018-08-08 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE |
| Generic Name | MIJ NEEDLE, TUMOR LOCALIZATION |
| Product Code | MIJ |
| Date Received | 2018-08-08 |
| Model Number | NA |
| Catalog Number | DKBL-20-9.0-A |
| Lot Number | 8920426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-08 |