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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info) requested but not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a surgical procedure, the tip of the beacon tip catheter separated within the patient.The separated tip was retrieved.Additional information requested, however it was not provided at the time of this report.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review device record history, instructions for use (ifu), documentation, quality control, specifications and visual inspection of the returned device was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: "due to thinwall 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." "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." the visual examination reported the inspection of the beacon tip confirms material degradation.This product is in scope of the recall.A capa has previously been opened to investigate this failure mode.
Event or Problem Description
During a surgical procedure, the tip of the beacon tip catheter separated within the patient.The separated tip was retrieved.Additional information requested, however it was not provided at the time of this report.

• 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: 5623942
• Report Number: 1820334-2016-00264
• Device Sequence Number: 13542060
• Product Code: DQO
• UDI-Device Identifier: 00827002095489
• UDI-Public: (01)00827002095489(17)180803(10)6064887
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HNBR5.0-38-40-P-NS-KMP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2016
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2016
• Supplement Report FDA Received Date: 09/13/2016
• 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: 1820334-14APR2016-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention