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

Model Number G06005

Device Problems Crack (1135); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

As reported, during a procedure involving ligation of the right great saphenous vein using local anesthetic, a torcon nb advantage angiographic catheter fractured.Resistance was encountered upon advancement of the device.The user pulled the catheter back for re-delivery; however, resistance was still reported.The catheter was then removed from the patient and the device was found to be fractured.Another device was used to successfully complete the procedure.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.

Event Description

Additional information was received 23dec2020.The tip was cracked.The device did not separate.

Manufacturer Narrative

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

Correction: h6: medical device problem code grid.Based upon updated information received on 23dec2021 the tip on the device split and did not separate.A review of previous complaints showed that there has not been a precedent for reporting split tips for this device.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death or serious injury and there is no precedence of this malfunction leading to an adverse event.H1: our system requires this field to be populated and still reflects "malfunction" there was no reportable device malfunction.See note directly above this note.Description of event: as reported, during a procedure involving ligation of the right great saphenous vein using local anesthetic, a torcon nb advantage angiographic catheter cracked.Resistance was encountered upon advancement of the device.The user pulled the catheter back for re-delivery; however, resistance was still reported.The catheter was then removed from the patient and the device was found to be cracked.Another device was used to successfully complete the procedure.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use: ¿if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a component failure without manufacturing or design deficiency contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information to report.

• Brand Name: TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11004141
• MDR Text Key: 223787428
• Report Number: 1820334-2020-02291
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002060050
• UDI-Public: (01)00827002060050(17)230625(10)13266815
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

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 Expiration Date: 06/25/2023
• Device Model Number: G06005
• Device Catalogue Number: HNB5.0-38-100-P-NS-H1
• Device Lot Number: 13266815
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 02/25/2021
• Supplement Dates FDA Received: 12/29/2020; 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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
• Patient Age: 51 YR