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

Model Number	G27713
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during the angiogram portion of a transarterial chemoembolization(tace) procedure, the hub of the torcon nb advantage angiographic catheter did not fit adequately with the 20 ml syringe, causing a leak.The procedure was being performed through the femoral artery.Another torcon nb advantage angiographic catheter was used to successfully complete the procedure.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
It was originally reported that a torcon device was used to complete the procedure; however, the sales representative remarked that it was most likely a cook product.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the hub was securely attached.In order to test for leakage, a 20 cc luer-locking syringe was attached, and an attempt was made to flush the device; however, it was not possible.A 0.035 wire guide was then passed through the device, and biomatter exited to the distal tip.The syringe was attached again, and subsequent attempts to flush the device with water were successful.No leaks were noted at the connection of the hub and syringe.As a result, the reported failure mode could not be reproduced.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.The reported failure mode could not be reproduced.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.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
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b5, d10 - product received on.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
Upon further review of this complaint file, the reportability decision has been updated to reflect a non-reportable product malfunction.This complaint was mistakenly reported.According to our risk documentation, in the event that a leakage is observed from the junction of the proximal fitting to shaft or syringe and the procedure is completed successfully with the same or alternative device, the severity has been determined to be "negligible harm.".

• 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
• MDR Report Key: 7678216
• Report Number: 1820334-2018-02011
• Device Sequence Number: 13665049
• Product Code: DQO
• UDI-Device Identifier: 00827002277137
• UDI-Public: (01)00827002277137(17)210122(10)8463628
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

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: 01/22/2021
• Device Model Number: G27713
• Device Catalogue Number: HNB5.0-38-75-P-NS-RH
• Device Lot Number: 8463628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 07/18/2019
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 11/15/2018; 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1