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

Model Number	N/A
Medical Device Problem Codes	Failure to Advance (2524); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: supervisor.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 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.
Event or Problem Description
It was reported that a retracta detachable embolization coil was difficult to deploy.The device was required for embolization of a splenic vessel.Access was gained, then the user advanced the coil through a 5fr catheter.However, only 2 loops of the coil were able to be advanced into the patients anatomy.Additional information regarding the event has been requested but is currently unavailable.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: (b)(6) hospital (united states) informed cook on 30jun2022 of an event involving a retracta detachable embolization coil (rpn: mwcer-35-7-6, lot: 14270743).It was reported that there was difficulty advancing the coil out of the catheter, and it became stuck partially deployed.There were no adverse effects reported to the patient due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One used device was received for evaluation.The coil was found to be partially exiting the distal tip of the catheter.The delivery wire was unable to be advanced or retracted.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14270743 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were two other complaints associated with the final product lot number, in which both devices were found to be within specification.Cook also reviewed product labeling.The current instructions for use [t_mwcer_rev5] state the following: "precaution prior to introduction of the embolization coil, flush the angiographic catheter with saline." evidence gathered upon review of the dmr, dhr, and product labeling does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the device had difficulty advancing due to the catheter not being flushed, but due to the lack of information, this cannot be confirmed.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: following a review of the file and risk documentation, it was determined that this event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.A detailed search of current reporting software has not indicated an event that has led to patient injury or harm.As the retracta coil is attached to the delivery wire until deployment, a partially protruded coil can be retracted back into the catheter.As there is no heightened patient risk, this event is not reportable.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.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15001036
• Report Number: 1820334-2022-01201
• Device Sequence Number: 1596791
• Product Code: KRD
• UDI-Device Identifier: 10827002341880
• UDI-Public: (01)10827002341880(17)261024(10)14270743
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-7-6
• Device Lot Number: 14270743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 02/17/2023
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 02/13/2023; 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR COBRA LL CATHETER
• Patient Sex: Unknown