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

Model Number	G10822
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) number: pre-amendment.Device evaluation has begun; however, a conclusion is not yet available.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As initially reported, prior to patient contact during a cardiac catheterization, two torcon nb advantage angiographic catheters leaked at the hub while flushing the devices (a non-reportable event for this device).Upon return of the complaint devices, holes were noted three millimeters from the tips of the devices.The devices reportedly did not make contact with the patient.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that two prior-to-use hnb4.1-35-80-p-ns-jr2.5 catheters were returned for investigation.No biomatter was noted on either device.During the functional test, each catheter was clamped with hemostats, and leakage was detected where the tubing enters the cap.Damage was noted on both sides of the tip at 3mm from the distal tip.The damage appeared to have been due to perforation.The distal tip was then clamped, and when the catheter was flushed, water exited from the perforated area in the tip.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.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the examination of the returned product, investigation has concluded that the device failure is most likely attributable to the shipping and storage of the device.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8901358
• Report Number: 1820334-2019-02029
• Device Sequence Number: 216328
• Product Code: DQO
• UDI-Device Identifier: 00827002108226
• UDI-Public: (01)00827002108226(17)220220(10)NS9503076
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 02/20/2022
• Device Model Number: G10822
• Device Catalogue Number: HNB4.1-35-80-P-NS-JR2.5
• Device Lot Number: NS9503076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1