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

Model Number	G34197
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following event regarding retracta detachable embolization coils was reported vie the literature article: nassar, m.; holt, m.; afifi, a.M.; nazzal, m.An uncommon complication of coil embolization: coil deployment system malfunction leading to retained intra-aortic wire.J.Vasc.Surg.Cases innov.Tech.2026, 12, https://doi.Org/10.1016/j.Jvscit.2026.102155.Case report "a 52-year-old woman with a past medical history of noonan syndrome and hyperlipidemia who was admitted owing to lethargy and acute kidney injury.Noonan syndrome is a genetic disorder that is associated with short stature, characteristic facies, and heart defects; some patients have coagulation defects.The patient subsequently developed shortness of breath and melena, which was attributed to upper gi bleeding.In addition, she was found to have submassive pulmonary embolism with right heart strain.It is unclear whether there was a contribution of the patient¿s history of noonan syn-drome to her coagulopathy, but it does raise suspicion.The patient was taken to the endovascular suite for endoscopic evaluation and intervention for the gi bleed and catheter-directed mechanical thrombectomy of the pulmonary arteries with inferior vena cava filter placement.Initially, the gi bleeding was found to be coming from the second part of the duodenum, and it was controlled with clipping.However, owing to recurrence of duodenal ulcer bleeding 1 day later, demonstrated on computed tomography angiogram of the abdomen and pelvis, the patient was taken back to the hybrid room for embolization of the gda, which was successfully done using two 0.035-14-6 mm cook retracta coils (fig 1), in a similar fashion as described below." "the post procedure course was further complicated by recur-rent duodenal ulcer bleeding a few days later, which was again demonstrated on computed tomography angiography of the abdomen and pelvis.A repeat angiogram showed active extravasation proximal to the previous coils, closer to the origin of the gda (fig 2).Repeat embolization was performed via a [competitor's] directional sheath using two additional 0.035-14-6 mm cook retracta coils.The tip of the sheath was selectively placed in the origin of the gda.The first coil was deployed with difficulty after multiple turns of the attached wire, but upon attempting to deploy the second coil, it failed to detach from the leading wire (fig 3).Multiple additional turns of the deployment system handle were attempted until the handle was released, thinking that the coil was appropriately released.However, angiography showed an unraveled coil, which was then snared out (fig 4).Upon inspection of the wire, it was found that the leading wire had broken, initially thought to be near the coil within the gda and celiac/hepatic artery." "on postprocedure day 3 from the repeat angiogram, a compute tomography angiogram of the abdomen and pelvis was performed owing to concern for recurrent upper gi bleeding (fig 5).It revealed a retained wire that extended from the embolization coil in the gda to the external iliac artery.The wire malfunction was presumed to have occurred owing to severing the wire at the handle of the deployment de-vice rather than at the junction with the coil.The device failure was reported to governing bodies and to the manufacturer.Initially, the plan was for wire and coil retrieval after patient stabilization, but owing to her morbid condition, the decision was made to bring her back for retrieval of the wire and possibly the coil as an outpatient.We discussed endovascular vs open retrieval because of concerns for possible remobilization of the coils to other organs, specifically to the liver.She was discharged to a skilled care facility in stable condition without antithrombotics owing to the recent gi bleed.The patient had planned to follow up after recovery from the skilled nursing facility, but unfortunately, she passed away 2 months later owing to a cardiac event." discussion "after discussion, some thoughts on how to avoid similar complications would be to abort the procedure if coil deployment is unsuccessful, or the use of other devices or agents for embolization.The deployment wire likely severed at the deployment handle, which we believe could have been from too many turns at the handle, because the coil was difficult to deploy." this report will capture the first coil that was difficult to deploy.The second device that experienced separation and retention of the delivery wire is captured under a report with patient identifier (b)(6).
Additional Manufacturer Narrative
H3 - device evaluated by mfg?: device not returned to manufacturer.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 or that a death or serious injury occurred; nor is it admission 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: 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: 25046317
• Report Number: 1820334-2026-00461
• Device Sequence Number: 13330597
• Product Code: KRD
• UDI-Device Identifier: 10827002341972
• UDI-Public: (01)10827002341972(17)270927(10)14979007
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: G34197
• Device Catalogue Number: MWCER-35-14-6
• Device Lot Number: 14979007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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: TOUR GUIDE DIRECTIONAL SHEATH
• Patient Age: 52 YR
• Patient Sex: Female