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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 07/29/2014

Event Type  Injury  

Event Description

An unk type of procedure was performed (b)(6) 2014 on a (b)(6) male pt with liver cancer.The catheter was kept inside the pt after the procedure.During imaging on (b)(6) 2014, it was found that the tip of catheter was disconnected.When the physician found this condition, he did not do any additional procedure on the pt according to the report.Pt has left the hospital; however, according to the report of complainant, the physician did not intend to retrieve the tip of catheter from the pt by now, and prepares to do endovascular exclusion on the pt's next visit.A section of the device did remain inside the pt's body and the pt will require additional procedures due to this occurrence.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

No product was returned; however, reviews of the complaint history, the ifu and qc specifications were performed during the investigation.There is a quality control inspection, verifying the surface of catheter is free of damage and excess bumps or roughness.It is also verified that there are no splits, nicks, damage, excess material or debris present.This product is shipped with and ifu; which states under precautions: "due to thinwall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoid whenever possible" / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." we are unable to determine with certainty why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per quality engineering risk assessment, the addition of this complaint does not change the occlusion that no further risk-reduction is required.

Event Description

An unknown type of procedure was performed (b)(6) 2014 on a (b)(6) male patient with liver cancer.The catheter was kept inside the patient after the procedure.During imaging on (b)(6) 2014, it was found that the tip of catheter was disconnected.When the physician found this condition, he did not do any additional procedure on the patient according to the report.Patient has left the hospital; however, according to the report of complainant, the physician did not intend to retrieve the tip of catheter from the patent by now, and prepares to do endovascular exclusion on the patients next visit.A section of the device did remain inside the patient's body and the patient will require additional procedures due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, device history record, specifications, documentation, and instructions for use (ifu) of the product was conducted.The complaint device was not returned.Therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.This device was indwelling in the patient from (b)(6) 2014 to (b)(6) 2014 or longer.This device is categorized as a limited exposure device (contact less than or equal to 24 hours).The device is not intended to be used in this manner, and therefore it is unknown what forces may have been applied to the device.This product is in scope of the recall 1820334-29jun2015-002-r.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, "store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred." due to the product not being returned, we are unable to confirm the material degradation failure mode.However, it is likely that the off label use contributed to tip separation.A capa has previously been opened to investigate tip material failure due to material degradation.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.

Event Description

An unknown type of procedure was performed (b)(6) 2014 on a (b)(6) male patient with liver cancer.The catheter was kept inside the patient after the procedure.During imaging on (b)(6) 2014, it was found that the tip of catheter was disconnected.When the physician found this condition, he did not do any additional procedure on the patient according to the report.Patient has left the hospital; however, according to the report of complainant, the physician did not intend to retrieve the tip of catheter from the patient by now, and prepares to do endovascular exclusion on the patient's next visit.A section of the device did remain inside the patient¿s body and the patient will require additional procedures due to this occurrence.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 4128899
• MDR Text Key: 21173313
• Report Number: 1820334-2014-00450
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: N/A
• Device Catalogue Number: HNBR5.0-35-80-P-NS-C2
• Device Lot Number: 4822288
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: 08/22/2014; 08/22/2014
• Supplement Dates FDA Received: 10/08/2014; 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1820334-29JUN2015-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR