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

Model Number	G05955
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number: pre-amendment.Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, photos were provided by the complainant.A document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The product ifu instructs the user not to use the product if there if doubt as to whether the product is sterile and advises the user to inspect the product to ensure no damage has occurred upon removal from package.Based on the information provided and no product returned, investigation has concluded the cause of this device can be traced to a manufacturing deficiency.Appropriate measures have been initiated to address this failure mode.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.
Event or Problem Description
It was reported, after receipt of a roadrunner the firm hydrophilic wire guide at the distribution facility, a piece of hair was observed inside of the sealed primary packaging.This was observed during initial inspection and was not used for patient care.Per the initial reporter, the complaint device will not be returned to the manufacturer to aid in the investigation.

• 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: 8640927
• Report Number: 1820334-2019-01288
• Device Sequence Number: 2446198
• Product Code: DQO
• UDI-Device Identifier: 00827002059559
• UDI-Public: (01)00827002059559(17)211201(10)9321104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: No Information
• Device Expiration Date: 12/01/2021
• Device Model Number: G05955
• Device Catalogue Number: HNB5.0-38-80-P-NS-C2
• Device Lot Number: 9321104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1