MAUDE Adverse Event Report: COOK INC KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE; MIJ NEEDLE, TUMOR LOCALIZATION

Catalog Number	DKBL-20-9.0-A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.".
Additional Manufacturer Narrative
H6: method code: (4114) device not returned.Results code: (114) operational problem identified.Conclusion code: (61) unintended use error caused or contributed to event.Investigation - evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions and quality control of the device conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer did provide imaging of the patient, but the images provided were taken prior to hook wire migration.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.It was possible that migration was caused by tortuous patient anatomy, as it was stated by the customer that the target area consisted of a small tumor surrounded by a large fatty mass.It was also reported that the device was in the patient overnight.It is reasonable to believe that patient motion during the time between the device implantation and the excision could have contributed to the device migration.Another possible cause could be the improper taping of the outside of the device to the patient, however this is unlikely, as the customer reported taping the device after placement.It is concluded that unintended use error possibly contributed to the complaint event.The appropriate personnel were notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE
• Common Device Name: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7764652
• Report Number: 1820334-2018-02270
• Device Sequence Number: 11082756
• Product Code: MIJ
• UDI-Device Identifier: 00827002025875
• UDI-Public: (01)00827002025875(17)230531(10)8920426
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: DKBL-20-9.0-A
• Device Lot Number: 8920426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other