MAUDE Adverse Event Report: COOK INC MREYE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: event occurred sometime in (b)(6) 2018.Occupation: quality coordinator.Pma/510(k): k150931.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 a mreye embolization coil was used in an (b)(6) male patient for a/v fistulogram.The reports states the following: ¿patient has a left upper extremity brachiocephalic fistula placed for dialysis about one year ago.It has not been used for dialysis ever.Patient seen in clinic and noted to have a tortuous cephalic vein with multiple side branches noted on physical exam.The fistulogram was then obtained which showed that there was no arterial stenosis and again cephalic vein was noted to be tortuous with multiple side branches." physician further reports, ¿i placed a coil in one of the side branches which was successful.I wanted to do a completion angiogram and ended up dislodging the coil with my own hand in an attempt to have the wire and catheter passed through the tortuous cephalic vein." it is further stated, "coil was noted to be seen next to the retrograde sheath and the cephalic vein.I then attempted to use a snare to retrieve the coil back, i was able to retrieve the coil into the snare but as i was pulling back into the sheath, the coil dislodged and moved forward.I then followed the coil into the chest and found on the ap projection to be over the heart but not moving with beats of the heart.On the lateral view, it was not in the patient's heart but in the lungs.¿ no other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The device was not retrieved from the patient, so failure analysis could not be performed.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 showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number (7186111).There is no evidence to suggest nonconforming product exists in house or out in the field.Based on the information provided, no returned product, and the results of the investigation, it was concluded that user technique likely contributed to the failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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.(necessary) - attachment: [pr262336_hhs_fda_3500a_0501290000_2019_8001_recvd 24apr2019_mnp.Pdf].
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Event description: additional information was provided on (b)(6) 2019.A chest ct confirmed the coil in a left lower lobar artery and non-obstructive.It was determined no further intervention was needed.It was also stated the patient was discharged on "hd #6." this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
See h10.

• Brand Name: MREYE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8583227
• Report Number: 1820334-2019-01105
• Device Sequence Number: 1975231
• Product Code: KRD
• UDI-Device Identifier: 00827002424098
• UDI-Public: (01)00827002424098(17)210822(10)7186111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

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: 08/22/2021
• Device Model Number: N/A
• Device Catalogue Number: IMWCE-35-3-4
• Device Lot Number: 7186111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 06/11/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/30/2019; 06/18/2019
• 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
• Patient Age: 81 YR
• Patient Weight: 68