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

Model Number N/A

Device Problem Tip breakage (1638)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 08/21/2014

Event Type  Injury  

Event Description

A procedure was performed (b)(6) 2014 on a (b)(6) year old male patient with carcinoma of urinary bladder.After the procedure, the catheter was kept inside the patient.During imaging on (b)(6) 2014, it was noted that the tip of catheter had disconnected.The tip of catheter had fallen into a blood vessel from the right side of internal iliac artery.When the physician found this condition, he did not perform any additional procedures on the patient according to the report.Patient was still in the hospital.According to the report of complainant, the physician did not intend to retrieve the tip of catheter from the patient by now.According to the initial reporter, the patient did not experience any adverse effects dur to this occurrence.

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).Event is still under investigation.

Manufacturer Narrative

No product was returned for evaluation.During the course of investigation, a review of the complaint history, instructions for use (ifu), and quality control (qc) was conducted.Per quality control specification, there is a verification that the surface of catheter is free of damage and excess bumps or roughness and that the wire braided catheter surface is free of exposed wires.The distal tip/endhole is also verified to be rounded smooth, not thin, slanted, or out of round and that no splits, nicks, damage, excess material or debris present.This product is shipped with an instructions for use (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." based on the information provided, we are unable to determine with certainty the root cause of this reported difficulty the appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Quality engineering risk assessment (qera) was used to assess the risk of this complaint.It was concluded that no further risk reduction is required.

Event Description

When the physician found this condition, he did not do any additional procedure on the patient according to the report and did not intend to retrieve the tip of catheter from the patient by now.Patient was still in the hospital.According to the initial reporter, the patient did not experience any adverse effects.

Manufacturer Narrative

(b)(4).**** event evaluation **** during the course of the investigation, a review of the complaint history, quality control, device history record, instructions for use (ifu), documentation, and specifications of the product was conducted.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 was not intended to be used in this manner.Therefore, it is unknown what forces may have been applied to the device.On 02 july 2015, a recall was initiated on any product manufactured with certain lot numbers.A recall expansion was initiated on 07 october 2015 for additional product.Another recall expansion was initiated on 15 april 2016 for any product manufactured with the beacon tip technology.This product is in scope of the recall.Due to the product not being returned, we were unable to confirm the material degradation failure mode.However, it was likely that the off label use contributed to the tip separation.A capa was previously opened to investigate tip material failure due to material degradation.This complaint will conservatively be accepted for this capa.We will continue to monitor for similar complaints.

Event Description

A procedure was performed (b)(6) 2014 on a (b)(6) male patient with carcinoma of urinary bladder.After the procedure, the catheter was kept inside the patient.During imaging on (b)(6) 2014, it was noted that the tip of catheter had disconnected.The tip of catheter had fallen into blood a vessel from the right side of internal iliac artery.When the physician found this condition, he did not do any additional procedure on the patient according to the report and did not intend to retrieve the tip of catheter from the patient by now.Patient was still in the hospital.According to the initial reporter, the patient did not experience any adverse effects.

• 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
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4209305
• MDR Text Key: 4984900
• Report Number: 1820334-2014-00449
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002112025
• UDI-Public: (01)00827002112025(17)170301(10)4822288
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Unknown
• 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

• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2014
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/01/2015; 10/18/2016
• 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
• Patient Age: 68 YR