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 Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During the procedure, the tip broke off of the catheter and lodged in the hepatic vein.The device was removed with a snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of the complaint history, device history record, documentation, instructions for use (ifu) and quality control 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 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 shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Due to product not being returned, we are unable to confirm material degradation failure mode.A capa request was initiated as part of the recall actions to further investigate the incident.This product is in scope of the recall, therefore this complaint will conservatively be accepted as part of the capa.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
During the procedure, the tip broke off of the catheter and lodged in the hepatic vein.The device was removed with a snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5575972
• Report Number: 1820334-2016-00241
• Device Sequence Number: 404790
• Product Code: DQO
• UDI-Device Identifier: 00827002086258
• UDI-Public: (01)00827002086258(17)171017(10)5354875
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2016

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: HNBR5.0-38-65-P-NS-SIM2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2016
• Device Age: 18 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2016
• Supplement Report FDA Received Date: 09/15/2016
• 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: 1820334-29JUN2015-002-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention