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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event was not provided.Weight of patient at time of event was not provided.(b)(4).Event is currently under investigation.
Event or Problem Description
During the case the radiopaque tip of the catheter broke off from the shaft leaving the tip in the superior mesenteric artery.It was completely snared and retrieved.No known adverse effect to patient was reported.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of complaint history, device history record, documentation , instructions for use (ifu), specification, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: 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." "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 device confirms material degradation of the beacon tip this product is in scope of the beacon tip recall.A capa has previously been opened to investigate this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
During the case the radiopaque tip of the catheter broke off from the shaft leaving the tip in the superior mesenteric artery.It was completely snared and retrieved.No known adverse effect to patient was reported.

• Brand Name: TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5548206
• Report Number: 1820334-2016-00204
• Device Sequence Number: 16325144
• Product Code: DQO
• UDI-Device Identifier: 00827002137929
• UDI-Public: (01)00827002137929(17)180225(10)5655438
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2016

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: HNBR5.0-35-65-P-NS-VANSCHIE3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2016
• Device Age: 13 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2016
• Supplement Report FDA Received Date: 08/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention