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 Codes	Pain (1994); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/09/2016
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 during a cerebral angiography procedure, upon entry to the subclavian artery the tip broke off of the catheter.The tip traveled to pulmonary artery.The physician intervened by using a 3frx12mm pfm snare to retrieve the tip from pulmonary artery.The retrieval procedure took an estimated 4 hours and the tip was retrieved.It is noted that the patient was conscious at the time of this event and experienced discomfort.No additional details have been received.
Additional Manufacturer Narrative
Information received by the site indicated that during the retrieval of the separated tip, the patient was conscious and experienced "unimaginable uncomfort".Due to the high risk of the retrieval procedure, a cardiovascular physician was present; however, the treating physician refused assistance and retrieved the tip on his own.(b)(4).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 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 noted two non-conformances; one for "damaged" and fifteen for "tip/taper, inadequate, incomplete or missing".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 are 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." based on the information provided, no product returned and the results of the investigation, the most likely root cause of the reported event was determined to be manufacturing related.Measures are currently being conducted to address this failure mode.We will continue to monitor 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: 6294347
• Report Number: 1820334-2017-00224
• Device Sequence Number: 13586421
• Product Code: DQO
• UDI-Device Identifier: 00827002084711
• UDI-Public: (01)00827002084711(17)181028(10)NS6319579
• 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: Notification,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: HNBR5.0-35-100-P-NS-SIM1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/09/2016
• 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: 49 YR