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

Catalog Number HNB5.0-38-80-P-NS-RH

Device Problem Break (1069)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

As reported, upon opening the device packaging prior to use, a torcon nb advantage angiographic catheter was bent.The device was not used, and the procedure was completed with another device.There were no adverse effects to the patient.The package was not damaged.Upon return of the device to the distributor, the distributor noted that the "plastic cap at the tip of the catheter was found to be missing".Photos provided by the distributor possibly show separation of the catheter tip.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = address:(b)(6).G4: pma/510(k) number = pre-amendment.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, unavailable, or unchanged.Corrected information: b1, h1 = upon return and evaluation of the device, although the catheter was bent just below the hub/strain relief, no separation was noted.The catheter and catheter tip were intact.The investigation concluded that the missing plastic cap described by the distributor is likely the ¿snap pack casing¿, which is part of the packaging that is intended to protect the catheter tip.The missing plastic cap was reported by the distributor after the opened device was returned from the customer.The customer did not report that anything was missing from the device.Therefore, it is assumed that the opened device was returned to the distributor without the ¿snap pack casing¿.There is no evidence that the device was non-conforming.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that a missing snap pack casing would be likely to cause or contribute to a death or a serious injury.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the event which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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: 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: 17886416
• MDR Text Key: 325101126
• Report Number: 1820334-2023-01346
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002059740
• UDI-Public: (01)00827002059740(17)260428(10)15412230
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HNB5.0-38-80-P-NS-RH
• Device Lot Number: 15412230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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