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

Model Number N/A

Device Problems Material Separation (1562); Stretched (1601); Difficult or Delayed Separation (4044)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that the delivery wire of a retracta detachable embolization coil separated.The device was required for varicocele embolization of a 6 mm left gonadal vein.The coil formed properly in the vessel.However, when attempting to detach the coil utilizing the torque device, the delivery wire spun, but the coil would not detach.The user then attempted to retract the coil and encountered tension.It was discovered that the delivery wire was stretched and unravelling."the wire finally broke off after he tried pulling it because he could not do anything else." about 120 cm of the delivery wire was removed; however, a portion of the wire remained attached the coil and was retained in the patient.No other adverse effects were reported for this incident.

Manufacturer Narrative

Initial customer (person): street: (b)(6).Initial reporter occupation: chief interventional technologist.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b2.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.

Manufacturer Narrative

Investigation ¿ evaluation: on (b)(6) 2022, a representative of atlantic medical imaging (united states) reported to cook that the delivery wire of a retracta detachable embolization coil (rpn: mwcer-35-14-8; lot#: 14655297) separated.The device was required for varicocele embolization of a 6 mm left gonadal vein.The coil formed properly in the vessel.However, when attempting to detach the coil utilizing the torque device, the delivery wire spun, but the coil would not detach.The user then attempted to retract the coil and encountered tension.It was discovered that the delivery wire was stretched and unravelling."the wire finally broke off after he tried pulling it because he could not do anything else." about 120 cm of the delivery wire was removed; however, a portion of the wire remained attached the coil and was retained in the patient.No other adverse effects were reported for this incident.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.Upon visual inspection, the device was noted be elongated starting right at the solder joint near the distal end.The damage to the device prevented cook from measuring it to check against specification.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 shr for the reported complaint device lot 14655297 revealed no related non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The ifu [t_mwcer_rev5] packaged with the device contains the following in relation to the reported failure mode: ¿precautions¿ prior to introduction of the embolization coil, flush the angiographic catheter with saline¿ instructions for use¿ 5.Remove the delivery wire holder and the metal loading cartridge from the catheter hub while holding the delivery wire stationary¿ 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.8.If the coil position is correct, use the torque device to turn the delivery wire counterclockwise 8-10 times, until coil detachment can be either felt or visualized under fluoroscopy.Note: it is recommended that the junction remain just inside the tip of the catheter¿ the information provided upon review of 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, 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 wrong sized coil was used and became stuck in the vessel, making it difficult to retract, 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 14988072
• MDR Text Key: 295708513
• Report Number: 1820334-2022-01194
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341989
• UDI-Public: (01)10827002341989(17)270408(10)14655297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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-35-14-8
• Device Lot Number: 14655297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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: MWCE-35-14-10-NESTER-01 QTY 2; MWCE-35-5/3-TORNADO-01 QTY 5; MWCER-35-14-8 QTY 5
• Patient Outcome(s): Disability; Other