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	Foreign Body In Patient (2687)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).User facility phone number was not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During the tace procedure on (b)(6) male patient, the surgeon said that the tip of catheter was detached inside the patient body.It flowed with blood to femoral profound artery.The user tried to fetch out the broken part with gooseneck snare but failed.A second attempt failed to take out the detached part with gooseneck snare.X-ray revealed the detached part fell into the deep arterial branch, where it could not be fetched out.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: the complaint device was not returned.Therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.During the course of the investigation, a review of the complaint history, quality control, device history record, documentation, and instructions for use (ifu) of the product was conducted.This device was manufactured with a lot number which corresponds to a raw material recall.A recall was initiated on 02jul2015.The recall was expanded on 07oct2015 and 15apr2016.This product is in the scope of the recall.This product is shipped with an ifu which states under 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." additionally, the product should be "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." due to the product not being returned, we are unable to confirm a material degradation failure mode.However, a capa has previously been opened to investigate this failure mode.This complaint will conservatively be accepted for this capa.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.
Event or Problem Description
During the tace procedure on (b)(6) male patient, the surgeon said that the tip of catheter was detached inside the patient body.It flowed with blood to femoral profound artery.The user tried to fetch out the broken part with gooseneck snare but failed.A second attempt failed to take out the detached part with gooseneck snare.X-ray revealed the detached part fell into the deep arterial branch, where it could not be fetched out.

• 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: 5636576
• Report Number: 1820334-2016-00271
• Device Sequence Number: 564108
• Product Code: DQO
• UDI-Device Identifier: 00827002278523
• UDI-Public: (01)00827002278523(17)160901(10)4506339
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2016

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: HNBR5.0-38-80-P-NS-RH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/30/2016
• Device Age: 31 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 10/11/2016
• 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: Z-2610-2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 65