MAUDE Adverse Event Report: COOK INC AUROUS CENTIMETER VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G11916
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pre-amendment 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 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
It was reported that a foreign body was discovered inside the packaging of the 'aurous centimeter vessel sizing catheter'.The issue was noted during device inspection within a distribution facility, therefore, there is no patient involvement.
Additional Manufacturer Narrative
Summary of event: it was reported that a foreign body was discovered inside the packaging of the 'aurous centimeter vessel sizing catheter'.The issue was noted during device inspection within a distribution facility, therefore, there is no patient involvement.Corrected information: d4 = udi.Investigation evaluation: reviews of the complaint history, device history record (dhr), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation; however, photos were provided, which confirm foreign matter within the sealed package.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on one device from the lot; however, the affected product was reworked, and the lot was 100% reinspected.A review of complaint history found no additional complaints for this lot number.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and investigation of device photos suggests that there is evidence the device was manufactured out of specification.Although one relevant non-conformance was noted on the lot, the non-conforming product was reworked and the lot was 100% reinspected, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a quality control deficiency contributed to this event.Responsible personnel were notified.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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: AUROUS CENTIMETER VESSEL SIZING CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 22393938
• Report Number: 1820334-2025-00821
• Device Sequence Number: 21113865
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)271119(10)16347556
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 12/02/2025

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 Model Number: G11916
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Device Lot Number: 16347556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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
• Patient Sex: Unknown