MAUDE Adverse Event Report: COOK INC HIGH-FLO SILVER ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during a diagnostic cerebral procedure using a high-flo silver angiographic catheter, the hub popped off the h1 catheter.The end user advanced the catheter, tried to inject and the hub came off.The catheter was removed without incident.The patient was unharmed and no additional procedures were needed.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and results of the investigation a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• Brand Name: HIGH-FLO SILVER ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6623436
• Report Number: 1820334-2017-01292
• Device Sequence Number: 16327906
• Product Code: DQO
• UDI-Device Identifier: 00827002030725
• UDI-Public: (01)00827002030725(17)190225(10)NS6741886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/19/2017

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 Model Number: N/A
• Device Catalogue Number: HBP5.5-38-100-P-NS-H1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/19/2017
• Patient Sequence Number: 1