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

Model Number N/A

Device Problems Material Separation (1562); Tip breakage (1638)

Patient Problems Nonresorbable materials, unretrieved in body (2276); Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2014

Event Type  Injury  

Event Description

A procedure was performed (b)(6) 2014 on a male patient liver cancer.Catheter was kept inside the patient after the procedure.During imaging on (b)(6) 2014, the tip of the catheter was found to be disconnected.When the physician found this condition, he did not do any additional procedures on the patient according to the report.The patient has away by now.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

No product was returned to assist in the investigation.However, during the investigation process, reviews of complaint history, ifu, and quality control were conducted.Per qc specifications, the surface of the catheter is verified to be free of damage, excess bumps, roughness, splits, nicks, damage, and excess material or debris.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 avoided whenever possible" / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." the appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Quality engineering risk assessment was used to assess the risk of this complaint.The addition of this complaint does not change the conclusion that no further risk reduction is required.

Event Description

A procedure was performed (b)(6) 2014 on a male patient with liver cancer.Catheter was kept inside the patient after the procedure.During imaging on (b)(6) 2014, the tip of catheter was found to be disconnected.When the physician found this condition, he did not do any additional procedures on the patient according to the report.The patient has passed away by now.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of complaint history, device record history, instructions for use (ifu), documentation, quality control and specifications 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." this device was indwelling in the patient from (b)(6) 2014 to (b)(6) 2014.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.Due to product not being returned, we are unable to confirm material degradation failure mode.This product is in scope of the recall.Capa investigation 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 Description

A procedure was performed (b)(6) 2014 on a male patient with liver cancer.Catheter was kept inside the patient after the procedure.During imaging on (b)(6) 2014, the tip of catheter was found to be disconnected.When the physician found this condition, he did not do any additional procedures on the patient according to the report.The patient has passed away by now.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
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 4200987
• MDR Text Key: 20015827
• Report Number: 1820334-2014-00451
• 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?: Yes
• 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: (1)00827002112025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/22/2004
• Initial Date FDA Received: 09/15/2014
• Supplement Dates Manufacturer Received: 08/22/2004; 08/22/2004
• Supplement Dates FDA Received: 10/10/2014; 10/11/2016
• 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: Z-2610-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening