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

Model Number	G51836
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - device evaluated by mfg?: device evaluation anticipated but has not yet begun.Awaiting device return.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 device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that the snare of an indy otw vascular retriever separated from the catheter during a thoracic endovascular aortic repair (tevar) procedure for a 71-year-old male patient.A competitor pull-through wire was selected for insertion of the delivery system.The wire guide was advanced from the left brachial artery into the descending aorta.The indy otw vascular retriever was introduced via a competitor's 22fr sheath from the right femoral artery and the competitor wire was snared.During the attempt to retrieve the wire, the snare was severed.The remaining catheter was then removed from the patient.Fluoroscopic examination revealed that the severed portion of the device was slightly proximal to the 22fr sheath, around the thoracoabdominal region and remaining on the competitor wire used to guide the complaint device.As the 22fr sheath was already in place, a second competitor wire and indy otw vascular retriever were inserted to retrieve the severed snare tip.During retrieval, the severed snare became entangled with the second wire.As a result, a third indy otw vascular retriever was used to catch and pull the competitor wire, completing the pull-through.The severed snare tip was successfully removed from the patient, and the procedure was completed uneventfully as planned.It was noted that it did not appear that excessive force was being applied to the device at the time of separation.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.This report captures the indy otw vascular retriever snare that separated during the attempt to snare the competitor wire.

• Brand Name: INDY OTW VASCULAR RETRIEVER
• Common Device Name: 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: 24190574
• Report Number: 1820334-2026-00085
• Device Sequence Number: 9766942
• Product Code: MMX
• UDI-Device Identifier: 00827002518360
• UDI-Public: (01)00827002518360(17)270318(10)15952548
• Combination Product (Y/N): N
• PMA/510(K) Number: K160593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: G51836
• Device Catalogue Number: INDY-8.0-35-100-40
• Device Lot Number: 15952548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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: COOK INDY-8.0-35-100-40, LOT#: 16812453 X 2; GORE DRYSEAL 22FR. 33 CM; TERUMO RADIFOCUS 150CM X 2; TERUMO RADIOFOCUS 400 CM
• Patient Age: 71 YR
• Patient Sex: Male