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

Model Number	G34187
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a retracta detachable embolization coil became entangled during coil embolization procedure for the treatment of an abdominal aortic aneurysm in a patient of unknown age and gender.The procedure aimed to embolize the internal iliac artery via a contralateral approach using a left inguinal puncture.Since, there was aneurysm in the main internal artery, the intervention was planned to include the embolization of the superior and inferior gluteal arteries.The superior gluteal artery was successfully embolized without complications, during the embolization of the inferior gluteal artery, the first coil was placed, and the wire guide was rotated counterclockwise to detach the second coil, the junction zone was just inside the catheter tip upon attempted deployment.The first coil became entangled and could not be removed, both the coils were forcibly pulled into the catheter and then removed together with the catheter.The procedure was successfully completed using new retracta coils.In total, four coils including three retracta embolization coils and one packing coil (competitor¿s device) were placed in the inferior gluteal artery.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.This report captures the first coil.The second coil is referenced in a report with the patient identifier: (b)(6).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person): (b)(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.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, it was determined that this event is not reportable.The first coil (lot#15876592) placed did not migrate; it was removed due to a failure of the second coil.Therefore, there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the first coil placed.This complaint will be close/canceled by the manufacturer.The complaint on the second coil will remain open and has been captured in report 1820334-2024-01323.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.See h10.

• 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: 20423304
• Report Number: 1820334-2024-01322
• Device Sequence Number: 15418861
• Product Code: KRD
• UDI-Device Identifier: 10827002341873
• UDI-Public: (01)10827002341873(17)290131(10)15876592
• Combination Product (Y/N): N
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: G34187
• Device Catalogue Number: MWCER-35-7-4
• Device Lot Number: 15876592
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2024
• 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: COMPETITOR PACKING COIL.; COOK MWCER-35-14-6 X 3, LOT UNKNOWN.; COOK MWCER-35-14-6, LOT 15876596.; MERIT MEDICAL/ANGIOGRAPHIC CATHETER SH1.
• Patient Sex: Unknown