MAUDE Adverse Event Report: COOK INC INDY OTW VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2022

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a patient required an indy otw vascular retriever for placement of an iliac branch graft on a previously placed main body device.While attempting to grab the wire guide during the procedure, the lobes of the snare got caught on the bare metal stent of the main body device.The physician attempted to remove the snare with force, and the snare separated.The metal lobe of the snare remained hooked onto the main body in the patient.The iliac branch graft was placed via arm access.There is no planned retrieval of the snare fragment.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation health sciences north informed cook on (b)(6) 2022 of an event with a male patient involving rpn: indy-8.0-35-55-40 (product lot unknown).The lobes of the snare got caught on the bare metal stent of the existing evar during the procedure and separated.Instead of taking a second to evaluate the situation, the doctor yanked hard, and the snare came apart.The metal trilobed part of the snare remained in the patient hooked onto the main body graft and the physician has no plans to retrieve the separated portion of the device.It was reported the patient is doing fine.Reviews of documentation including the complaint history, drawing, quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The device was packaged with ifu t_indyotw_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device: ¿precautions manipulation of the product requires fluoroscopic control.Visually inspect the product before use to ensure it is undamaged.Instructions for use 4.Insert the retriever over-the-wire through an in situ guiding catheter or introducer sheath and advance it to the desired position.5.While holding the flexor sheath in position, loosen tuohy-borst and advance the inner catheter through the flexor sheath until the snare emerges from the distal tip.Note: the snare will expand upon emergence from the flexor sheath.6.Position the retriever so that the foreign body, such as a wire guide or catheter, is caught within the snare.While maintaining the snare position, slide the flexor sheath forward to capture the foreign body.7.Tighten tuohy-borst to maintain tension on the catheter controlling the foreign body, withdraw the retriever, including the snare and flexor sheath assembly, to a peripheral location and retrieve the foreign body.¿ after review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Based on the available information, no device return, and the results of the investigation, a definitive cause for the reported failure could not be established for this event.A possible cause that likely contributed to the separation of the device is excessive force applied during the procedure.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: INDY OTW VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• 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: 14240173
• MDR Text Key: 290548195
• Report Number: 1820334-2022-00665
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• PMA/PMN Number: K160593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• 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: INDY-8.0-35-55-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ILIAC BRANCH GRAFT
• Patient Outcome(s): Other
• Patient Sex: Male