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	04/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
Interventional radiologist was performing portal venous pressure monitoring and the tip of the catheter partially came apart from the actual catheter.The catheter tip was safely retrieved from the 57 year old female patient by carefully pulling back over the wire and pulling back into the sheath.The tip of the catheter then fell off as soon as it was out.No part of the device remained inside the patient as the catheter tip separated after the catheter was removed from the patient.The patient did not require any additional procedures and no adverse effects to the patient were reported 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), 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 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 inspection of the returned device reported the beacon tip shows circumferential separation in 3 locations.Microscopic images show signs of material degradation.A capa request was initiated as part of the recall actions to further investigate the incident.Root cause investigation indicates that processing and environmental factors contribute to the identified failure mode.This product is in scope of the recall, therefore this complaint will be accepted as part of the capa.This product was recalled under recall #z-2610-2016.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
Interventional radiologist was performing portal venous pressure monitoring and the tip of the catheter partially came apart from the actual catheter.The catheter tip was safely retrieved from the (b)(6) female patient by carefully pulling back over the wire and pulling back into the sheath.The tip of the catheter then fell off as soon as it was out.No part of the device remained inside the patient as the catheter tip separated after the catheter was removed from the patient.The patient did not require any additional procedures and no adverse effects to the patient were reported due to this occurrence.

• 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: 5673309
• Report Number: 1820334-2016-00339
• Device Sequence Number: 26824
• Product Code: DQO
• UDI-Device Identifier: 00827002137929
• UDI-Public: (01)00827002137929(17)170815(10)5197346
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 04/28/2016

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?: Yes
• 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: 04/28/2016
• Device Age: 20 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 09/22/2016
• 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: 57 YR