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

Model Number	G51836
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bottom side of the inner pouch of the indy otw vascular retriever was found to be unsealed during an endovascular abdominal aortic aneurysm repair (evar) procedure.The package was opened by the user and the inner pouch was removed.Upon removal, the device slipped out from the pouch.The device then fell on the floor and was no longer usable.Another device was opened to complete the procedure successfully.Upon examination of the packaging by the user, it was found that the inner pouch did not have a seal.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): postal code: (b)(4).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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that the bottom side of the inner pouch of the indy otw vascular retriever was found to be unsealed during an endovascular abdominal aortic aneurysm repair (evar) procedure.The package was opened by the user, and the inner pouch was removed.Upon removal, the device slipped out from the pouch.The device then fell on the floor and was no longer usable.Another device was opened to complete the procedure successfully.Upon examination of the packaging by the user, it was found that the inner pouch did not have a seal.The patient did not experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications for the device 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 (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 revealed no recorded non-conformances relevant to the failure mode.A complaint history search did not identify any other events associated with the reported device lot.Cook also reviewed product labeling.The device was packaged with ifu t_indyotw_rev6.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.Warnings: precautions: visually inspect the product before use to ensure it is undamaged.Do not use after the expiration date printed on the label.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Evidence provided by the complaint facility, device failure analysis, dhr, complaint history, and manufacturing documents concludes that the device was manufactured out of specification.Because all effected products have been recalled, no additional products remain in house or in the field.Based on the information provided, no product return, and the results of the investigation, cook has determined the event to be due to a manufacturing and quality control deficiency.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
• 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 ; 8128294891
• MDR Report Key: 19135278
• Report Number: 1820334-2024-00546
• Device Sequence Number: 17891087
• Product Code: MMX
• UDI-Device Identifier: 00827002518360
• UDI-Public: (01)00827002518360(17)260227(10)15244720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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 Expiration Date: 02/27/2026
• Device Model Number: G51836
• Device Catalogue Number: INDY-8.0-35-100-40
• Device Lot Number: 15244720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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
• Patient Sex: Unknown