MAUDE Adverse Event Report: COOK INC TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G09521
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = mobile: (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.
Event or Problem Description
As reported, during an angiogram, a torcon nb advantage angiographic catheter became stuck in the patient.Access was obtained in the femoral artery, and the catheter was advanced through another manufacturer¿s 5-french sheath, over another manufacturer¿s wire, to perform selective bronchial arteriography.The patient¿s vessels were reportedly distorted.Resistance was reportedly encountered as the device was passed under the clavicle.As the catheter was rotated for entry into the aorta, it became twisted/distorted/bent in the right iliac artery.Angiography was not successful, and the catheter could not be straightened or removed from the patient.The user obtained additional access via posterior puncture of the contralateral femoral artery.A sheath was placed, and an unspecified ¿catcher¿ was used to straighten the catheter, which was then successfully removed from the patient.A new catheter of the same type 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 due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, during an angiogram, a torcon nb advantage angiographic catheter became stuck in the patient.Access was obtained in the femoral artery, and the catheter was advanced through another manufacturer¿s 5-french sheath, over another manufacturer¿s wire, to perform selective bronchial arteriography.The patient¿s vessels were reportedly distorted.Resistance was reportedly encountered as the device was passed under the clavicle.As the catheter was rotated for entry into the aorta, it became twisted/distorted/bent in the right iliac artery.Angiography was not successful, and the catheter could not be straightened or removed from the patient.The user obtained additional access via posterior puncture of the contralateral femoral artery.A sheath was placed, and an unspecified ¿catcher¿ was used to straighten the catheter, which was then successfully removed from the patient.A new catheter of the same type 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 due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation; however, a photo was provided by the customer.The photo shows a kink in the catheter.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿ 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, ifu, and investigation of the device photo suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s distorted vessels/anatomy contributed to this event.As the catheter was rotated for entry into the aorta, it became twisted/distorted/bent in the right iliac artery.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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
**udi related data quality updates only** correction: d4.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.

• Brand Name: TORCON NB ADVANTAGE ANGIOGRAPHIC 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 ; 8128294891
• MDR Report Key: 18181945
• Report Number: 1820334-2023-01604
• Device Sequence Number: 18115227
• Product Code: DQO
• UDI-Device Identifier: 00827002095212
• UDI-Public: (01)00827002095212(17)251103(10)15052121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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: 11/03/2025
• Device Model Number: G09521
• Device Catalogue Number: HNB5.0-38-80-P-NS-C3
• Device Lot Number: 15052121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 02/15/2024; 08/06/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 03/08/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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: TERUMO 5F SHEATH, TERUMO LOACH WIRE.
• Patient Sex: Unknown