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

Catalog Number HNBR5.0-35-65-P-NS-VANSCHIE2

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): (b)(6).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.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

It was reported a torcon nb advantage van schie beacon tip seeking catheter separated at the hub.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Correction: the initial report was inadvertently submitted with a qe review date of 05dec2023 in the report reference information.This is incorrect as the qe review has yet to be performed.The date 05dec2023 is the date the report was submitted.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 or that a death or serious injury occurred; nor is it admission 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

Per additional information, no force was used when the hub separated from the catheter.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: h6 (annex e), h6 (annex f).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 or that a death or serious injury occurred; nor is it admission 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

Additional information was provided on 14dec2023.It was confirmed that the device made patient contact.It was noted that the device was not used with a power injector.The intended procedure was recanalization of the common iliac artery.The common iliac artery was stenosed with calcification, but no occlusion.An ipsilateral approach was used.A competitor's wire guide was used during the procedure.The access site was the left groin using a competitor's 6 french sheath.The access site was not scarred.The target location for the catheter was the infrarenal aorta.The fitting was washed down/wiped with a standard heparin solution.The catheter was advanced through the competitor's sheath.There was no resistance felt during advancement of the catheter.No devices were advanced through the catheter during the procedure.The physician used their right hand and single-handedly took the catheter out without any force or resistance.At this point the hub separated.No other ancillary devices were attached to the hub when separation occurred.The catheter shaft was carefully retracted from the patient.Everything was removed from the patient.The procedure was completed successfully as a stent was placed in the iliac artery.No unintended section of the device remained in the patient's body.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

It was reported a torcon nb advantage van schie beacon tip seeking catheter separated at the hub.The user stated that no resistance was felt during insertion or withdrawal, but the catheter hub came off during the removal.No unintended section of the device remained in the patient's body.The procedure was completed successfully as a stent was placed in the iliac artery.No adverse effects to the patient have been reported.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, the hub was separated.Glue was confirmed to be present on the proximal shaft and the hub.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.Cook reviewed the product labeling.The product ifu, t_hnb_rev2 ¿beacon tip catheters¿ provides the following information to the user related to the reported failure mode: "instructions for use 1.Inspect the packaging and device to verify no damage.Do not use the product if the catheter or packaging is damaged.How supplied upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the returned device evaluation, complaint file, dmr, dhr, and ifu does not indicate that the device was manufactured out of specification and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded that a component failure unrelated to the design or manufacturing of the complaint device caused the failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 VAN SCHIE BEACON TIP SEEKING 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: 18267929
• MDR Text Key: 329738514
• Report Number: 1820334-2023-01631
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K173289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2024

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: HNBR5.0-35-65-P-NS-VANSCHIE2
• Device Lot Number: 15551742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 12/14/2023; 02/23/2024
• Supplement Dates FDA Received: 12/13/2023; 12/19/2023; 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• 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
• Treatment: BOSTON SCIENTIFIC ZIP WIRE, 180 CM.; CORDIS BRITE TIP, 6 FR. 11 CM LONG.