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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 Description

It was reported a cook retracta detachable embolization coil was difficult to retract.The coil became adhered to possibly a graft structure when the catheter was deployed and could not be retracted.A piece of the device broke off and stayed attached to the main coil body when manipulating the coil.The coil and piece of device remained partially in the iliac.The overall end result was deemed well enough.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: b1, b2, h1, h6- annex e, annex f, annex g.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 Description

The device was received by cook on 02nov2022.A competitor's catheter, the coil delivery wire, the spiral delivery wire holder, and the metal loading cartridge were received.The delivery wire was stretched and elongated.Further inspection of the catheter discovered the distal end of the delivery wire was entrapped in the catheter.Upon removal, the junction between the delivery wire and coil was observed.No portion of the coil was present.The "part of the coil still attached to main coil body" has been reported under patient identifier (b)(6).

Event Description

Additional information received on (b)(6) 2022 in regards to the description of event.The wire did not separate in an unintended location.However, the wire appeared to break and coil detachment appeared to fail.The intended location of the coil in the body was the internal iliac artery.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) hospital (australia) informed cook on (b)(6) 2022 of an event that occurred on (b)(6) 2022 stating that a retracta detachable embolization coil (rpn: mwcer-35-14-14; lot: 14497829) was difficult to retract.The coil became adhered to possibly a graft structure when the catheter was deployed and could not be retracted.A piece of the wire broke off and stayed attached to the main coil body when manipulating the coil.The wire appeared to break and the coil detachment appeared to fail.However, the wire did not separate in an unintended location.The coil and piece of wire remained partially in the iliac.The intended location of the coil in the body was the internal iliac artery.No other adverse effects were reported for this incident.The coil and piece of wire which remained in the iliac artery of the patient is reported under mdr # 1820334-2022-01754.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.A competitor's blue catheter, a wire guide, and the coil loading cartridge attached to the spiral holder were returned.After trying to get the wire guide to pass through the catheter, strong resistance was noted near the distal tip.The catheter was placed in a sink filled with warm tap water to help clear away biological matter.Once removed from the sink and the tip of the catheter was cleaned off, a wire was noted sticking out from the tip.Using needle nosed pliers, the wire was pulled out and appeared to be the junction zone of the delivery wire.The delivery wire was lodged in the tip of the catheter causing the wire to not pass through and the wire was separated.It was also noted that the tip of the wire was stretched and elongated.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot 14497829 revealed no related non-conformances.A database search for complaints on the reported lot found one additional related complaint reported from the field that is related to this report.The information provided upon review of the device master record, product labeling, and device history record does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The ifu [t_mwcer_rev6] packaged with the device contains the following in relation to the reported failure mode: "instructions for use 1.Perform an angiogram and measure the diameter of the vessel to be occluded.6.Under fluoroscopic visualization, slowly advance the delivery wire until the entire length of the coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.Note: if significant resistance is encountered during coil advancement, do not continue advancing.Retract the delivery wire slightly, then gently re-advance it.If there is still significant resistance, withdraw the delivery wire from the catheter and try using a new coil with a shorter length." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible that the coil choice was the incorrect size for the vessel, but this cannot be definitively confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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: RETRACTA DETACHABLE EMBOLIZATION COIL
• Type of Device: 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: 15576126
• MDR Text Key: 301553929
• Report Number: 1820334-2022-01616
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002342016
• UDI-Public: (01)10827002342016(17)270216(10)14497829
• Combination Product (y/n): N
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-14
• Device Lot Number: 14497829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/02/2022; 12/27/2022
• Supplement Dates FDA Received: 11/21/2022; 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BLUE CATHETER BY ANGIO DYNAMICS
• Patient Outcome(s): Other
• Patient Sex: Male