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 2018-06-15 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-9.0-A manufactured by Cook Inc.
[111204506]
(b)(4). Pma/510(k) #: exempt. 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
[111204507]
It was reported a kopans modified breast lesion localization needle was used for intraoperative radiation therapy (iort) when the "thread" dislocated within the patient. This device complication led to radial surgery with ablation. Additional information regarding event details, patient status and procedure completion are unknown.
Patient Sequence No: 1, Text Type: D, B5
[116942688]
Investigation - evaluation: a review of the complaint history, documentation, instructions for use (ifu), drawings, manufacturer instructions, and quality control was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly, a review of the device history record could not be conducted. Per clinical assessment it is thought the "thread" may actually refer to the hookwire. The device is shipped with instruction for use (ifu) which notes: under no circumstances should a hookwire engaged in tissue be pulled out without surgical intervention. Precautions: the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for localization of breast lesions should be employed. Following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement. Damage to tissue adjacent to the needle is a known inherent risk of this device. This situation would likely be a worst case scenario where a separated portion of the device remained in the patient resulting in a radical procedure that caused serious harm. At this time, the most probable causes of this event are user technique, medical procedure and/or device failure related. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[116942689]
No new event description information to report at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01673 |
| MDR Report Key | 7605956 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-15 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2018-06-15 |
| 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 | 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 | 2018-06-15 |
| Catalog Number | DKBL-20-9.0-A |
| 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. Required No Informationntervention | 2018-06-15 |