MAUDE Adverse Event Report: COOK INC BEACON TIP AUROUS CENTIMETER VESSEL SIZING 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	01/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that a patient underwent treatment of an abdominal aortic aneurysm (aaa) with the cook alpha abdominal system using the beacon tip aurous centimeter vessel sizing catheter x.The procedure was completed according to plan.During the post-op ct, something strange was observed inside the lumen of the stentgraft.It can be seen in all projections but sagittal and axillary are most clear.It starts at the upper level of the bare stent (zimb) and goes inside the lumen downwards.It bifurcates and continues down each common iliac.It was determined that a fragment of the device, the peel away sheath, was left in the patient.It was reported that the patient did not experience any adverse effects at the time of the procedure, however the patient is going to require an additional procedure to remove the device portion.This was not identified at the time of the procedure.The plan is now to take the patient back to the hospital and see if they can visualize and possibly extract it.This is still in planning and at the time of this report, no secondary procedure has yet been scheduled or completed.
Additional Manufacturer Narrative
(b)(6).A review of the device history record, documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.Per the imaging review: a cta performed 1 month post-op dated (b)(6) 2017 was reviewed.Impression: "a catheter-type foreign body is seen within the main body device on follow up cta.This is free-floating proximally, but bifurcates distally within each end terminating along the stent graft wall at each proximal limb.This is likely from the time of repair or subsequent to it, as it is within the main body.The foreign body resembles the ¿peel-away¿ component of a catheter as noted in the complaint report." there is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6446475
• Report Number: 1820334-2017-00541
• Device Sequence Number: 587885
• Product Code: DQO
• UDI-Device Identifier: 00827002312166
• UDI-Public: (01)00827002312166(17)180819(10)6098250
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: NR5.0-35-100-P-10S-PIG-CSC-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 07/12/2017
• 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: 73 YR
• Patient Weight: 72