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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter also sent report to fda: unknown.Pma/510(k) #: k151676.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a retracta detachable embolization coil was selected for use for a venous embolization fistulogram in the patient's left arm.While attempting to deploy the coil, the coil would not detach from the delivery wire and was also difficult to retract.The inconel junction and part of the delivery wire eventually broke off into the patient during continuous attempts to deploy the coil.Additional questions regarding the event and patient outcome have been requested but are currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6 - additional methods code: communication/interviews (4111).Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a similar device for the same failure mode, reported in medwatch report #1820334-2019-01755, was returned for investigation.Analysis of this returned device confirmed elongation of the delivery wire, with the inconel junction detached.The solders appeared intact.Dimensional analysis could not be adequately performed due to the condition of the returned device, but there was no evidence to suggest the device was manufactured out of specification.The investigation captured in medwatch report #1820334-2019-01755 concluded that a definitive conclusion could not be established, but it was potentially related to unintended use error.Based on the similarities between the two devices, it is possible that the two complaints have the same cause for failure.Based on the known information, there is no evidence to suggest the device was not manufactured to the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for the final lot and the coil delivery wire subassembly lot revealed no related nonconformances.A database search revealed one other complaint was reported for the device lot, but was reported for an unrelated failure mode.There is no evidence to suggest there is any nonconforming product in house or out in the field.The device is shipped with instruction for use (ifu) which notes: device description: "the retracta detachable embolization coil is designed to be delivered under fluoroscopy to the target vessel." instructions for use: "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.Note: do not turn the delivery wire counterclockwise during advancement; the coil may be unintentionally detached.7.Verify correct position of the coil fluoroscopically.If coil position or placement is not satisfactory, the coil may be retracted into the catheter and re-deployed so long as there is no significant resistance.Note: it may be possible to perform a test injection of contrast media using a tuohy-borst sidearm adapter while the delivery wire is in the catheter.Note: if the size of the coil is not correct, gently remove the entire delivery wire and coil.Do not use the coil again.8.If the coil position is correct, use the torquw 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.Note: do not advance the delivery wire after coil detachment." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no returned product and the results of the investigation, it was concluded that component failure of the coil/delivery wire system without design or manufacturing issue contributed to the failure mode.It is possible that the delivery system was turned the incorrect direction, or too many times, leading to the separation of the inconel junction.It was reported that the coil was not deploying, and the delivery wire was "continuously turned" until the separation occurred.The ifu states to turn the system counterclockwise 8-10 times until the coil is released.The ifu further states to keep the junction within the tip of the catheter during deployment.If the junction was out of the catheter, it could have become damaged, leading to separation.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 or Problem 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
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9109487
• Report Number: 1820334-2019-02396
• Device Sequence Number: 3762750
• Product Code: KRD
• UDI-Device Identifier: 10827002341880
• UDI-Public: (01)10827002341880(17)240618(10)9780630
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2024
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-7-6
• Device Lot Number: 9780630
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR