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U.S. Department of Health and Human Services

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

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COOK INC BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problems Pain (1994); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
Event Date 04/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The reported event is currently under investigation.
 
Event 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.
 
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.
 
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Brand NameBEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
Type of DeviceDQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6294347
MDR Text Key66317113
Report Number1820334-2017-00224
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00827002084711
UDI-Public(01)00827002084711(17)181028(10)NS6319579
Combination Product (y/n)N
Reporter Country CodeVM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberHNBR5.0-35-100-P-NS-SIM1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2610/2623-2016

Patient Treatment Data
Date Received: 02/01/2017 Patient Sequence Number: 1
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