MAUDE Adverse Event Report: COOK INC SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event is currently under investigation.
Event or Problem Description
It was reported, that during a toce procedure, upon pushing the cook angiographic catheter to the entry of the hepatic artery, the tip separated, traveled to aorta.The cardiovascular doctor and on duty doctor intervened using a pfm snare to retrieve the tip.However due to the high flow of the aorta, the snare was pushed upward of the flow.The retrieval procedure for the tip, took hours to complete.The approximate amount of time was not provided.The tip was removed, no fragments remained within the patient.No additional information has been received.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, device history record, instructions for use (ifu), trends, and quality control of the device 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.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: precautions: "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, no product returned and the results of our investigation the most likely root cause may be related to the manufacturing process.Measures are being conducted internally to address this failure mode.We will continue to monitor for similar complaints.

• Brand Name: SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6294459
• Report Number: 1820334-2017-00222
• Device Sequence Number: 30824
• Product Code: DQO
• UDI-Device Identifier: 00827002119925
• UDI-Public: (01)00827002119925(17)180626(10)NS5963200
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K122937
• 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: SCBR5.0-38-100-P-NS-SIM2
• 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: 66 YR