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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event is currently under investigation.
Event or Problem Description
During a toce procedure, the catheter was pushed through a 0.035'' guidewire to the hepatic artery.As the catheter was advanced to the common iliac artery, the tip broke from the shaft.To prevent tip translocation into the aorta, the doctors intervened to removed the tip.The retrieval lasted approximately two hours.No fragments remain within the patient and the patient was unharmed.No additional information has been received.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, and quality control of the device was conducted during the investigation.The hospital had discarded the device implicated in this report therefore it was not returned and 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 noted one non-conformance for label reprints.A review of the product complaint history for this device indicates this is the second complaint associated with the complaint lot number.The device is shipped with an instruction for use (ifu) that describes the intended use and precautions: "due to thin wall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible." / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." additionally, "store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and the results of our investigation the root cause has been determined to be most likely related to the manufacturing process.Measures are being conducted internally to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: BEACON TIP 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: 6294622
• Report Number: 1820334-2017-00227
• Device Sequence Number: 1577314
• Product Code: DQO
• UDI-Device Identifier: 00827002278523
• UDI-Public: (01)00827002278523(17)181015(10)6273901
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HNBR5.0-38-80-P-NS-RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2610/2623-2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR