MAUDE Adverse Event Report: COOK INC BEACON TIP TORCON NB ADVANTAGE 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	04/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event is currently under investigation.
Event or Problem Description
When the device was introduced to the vessels with the assistance of a 0.035'' guidewire, the catheter was advanced to the hepatic artery.Upon reaching the hepatic artery, the tip broke.As the doctors began to remove the catheter, the tip traveled to the pulmonary artery.The patient experienced, panic, exhaustion and rage/anger.No additional information has been received.
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use (ifu), trends, and quality control was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed; however, a document-based investigation was performed.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were two other reported complaints for this lot number.Measures have been conducted to address this failure mode.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.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: 6294672
• Report Number: 1820334-2017-00229
• Device Sequence Number: 16251573
• Product Code: DQO
• UDI-Device Identifier: 00827002114845
• UDI-Public: (01)00827002114845(17)190208(10)6710249
• 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: HNBR5.0-38-100-P-NS-VERT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/15/2016
• 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