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

Catalog Number HNBR5.0-35-90-P-NS-RBT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

As reported, during a "ufe" procedure, the hub of a beacon tip torcon nb advantage angiographic catheter separated from the device.The catheter was reportedly buckling at the hub during the procedure.The device was removed, at which point the hub separated.The catheter was reportedly reinserted into the hub and the procedure was completed with the complaint device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = ir lab tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a "ufe" procedure, the hub of a beacon tip torcon nb advantage angiographic catheter separated from the device.The catheter was reportedly buckling at the hub during the procedure.The device was removed, at which point the hub separated.The catheter was reportedly reinserted into the hub and the procedure was completed with the complaint device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The hub was separated from the catheter.There was no remaining catheter material in the hub.Glue residue was noted on the catheter.The lot number was not provided to cook, and a search of devices sold and shipped to the customer was unable to definitively determine the lot number; therefore, it is unknown if there were any non-conformances or additional complaints on the lot.The ifu warns ¿if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿ the information provided upon review of the dmr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design, contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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 (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17221285
• MDR Text Key: 318209057
• Report Number: 1820334-2023-00843
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HNBR5.0-35-90-P-NS-RBT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1