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

Model Number	G11916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of an aurous centimeter vessel sizing catheter separated during angiography.A new device was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information has been requested.
Additional Manufacturer Narrative
E1: name and address =(b)(6) g4: pma/510(k) number = 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.
Additional Manufacturer Narrative
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
Additional information was received 30dec2024.Reportedly, contralateral femoral access was obtained for the tips (transjugular intrahepatic portosystemic shunt) procedure, and the target location was the pulmonary vein.The catheter was advanced through another manufacturer¿s 6-french sheath, over another manufacturer¿s 0.035-inch wire guide.The anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered during insertion or advancement of the catheter.A power injector was used with the device, with a maximum pressure of 800psi.Approximately four-to-five centimeters of the ¿head end of the catheter¿ separated outside of the patient; therefore, nothing needed to be removed from the patient.A new catheter was used to successfully complete the procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: b1, h1 = upon return and initial evaluation of the device on 14jan2025, the catheter material was not separated.The hub had detached from the catheter, and no catheter material remained in the hub.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 21026606
• Report Number: 1820334-2024-01690
• Device Sequence Number: 13038268
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)270515(10)16060624
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: G11916
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Device Lot Number: 16060624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 01/14/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/09/2025; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2024
• 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: BOSTON SCIENTIFIC AMPLATZ 0.035¿ 26CM; TERUMO 6FR 11CM SHEATH
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG