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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that a hair was observed inside the packaging of a torcon nb advantage angiographic catheter.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, and imaging of the returned device was conducted during the investigation.One unopened and unused torcon nb advantage angiographic catheter was returned for evaluation.Investigation of this device was completed via obtained imagery as the device was unable to be located.Foreign matter was noted inside the sealed package and appears to be a hair like fiber black in color, and approximately 4.0 centimeters (cm) in length.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing quality control, the entire package is inspected for defects.The product is rejected "if it contains any visible cuts, holes or foreign matter (dirt, hair, paper, fuzz, etc.)." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the foreign matter was determined to be manufacturing related.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 6818009
• Report Number: 1820334-2017-02706
• Device Sequence Number: 10795528
• Product Code: DQO
• UDI-Device Identifier: 00827002059887
• UDI-Public: (01)00827002059887(17)200717(10)8014242
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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 Model Number: N/A
• Device Catalogue Number: HNB6.0-38-100-P-2S-FA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1