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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hair was observed inside the primary packaging of a indy otw vascular retriever upon inspection by the distributor.The device did not make patient contact.
Additional Manufacturer Narrative
Occupation: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation elemar international forwarding informed cook on 19apr2022 of an incident involving an indy otw vascular retriever (indy-8.0-35-100-40) lot 14328222.On 18apr2022 during inspection of the received device a hair was noted inside the product packaging.Reviews of documentation including the complaint history, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of provided photos were conducted during the investigation.The complaint device was not returned to cook for investigation.However, two photos were provided which show a presumed hair inside the device packaging.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 dhr for the reported complaint device lot revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was shipped out of specification as foreign matter was not identified in the final inspection of the device/packaging.However, there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, t_indyotw_rev 5 ¿indy otw vascular retriever,¿ provides the following information to the user related to the reported failure mode: ¿precautions visually inspect the product before use to ensure it is undamaged 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.¿ based on the available information, provided photos, and the results of the investigation, cook has determined a manufacturing/quality control deficiency contributed to this incident.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 14286913
• Report Number: 1820334-2022-00681
• Device Sequence Number: 5408753
• Product Code: MMX
• UDI-Device Identifier: 00827002518360
• UDI-Public: (01)00827002518360(17)241103(10)14328222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Device Expiration Date: 11/03/2024
• Device Model Number: N/A
• Device Catalogue Number: INDY-8.0-35-100-40
• Device Lot Number: 14328222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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