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

Model Number	N/A
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): street: (b)(6).Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that upon removing a torcon nb advantage angiographic catheter from the box, the distributor found a hair inside the device packaging.As reported, there was no patient involved in this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Jainfeng medical device co.Ltd (taiwan) informed cook on 10feb2022 of an incident involving a torcon nb advantage angiographic catheter (rpn: hnb5.0-38-40-p-ns-kmp) from lot 14401405.When the catheter was removed from the box it was discovered that there was a hair in the package.This was discovered at the distributor.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as a visual inspection of the returned device were conducted during the investigation.One torcon nb advantage angiographic catheter was received in unused condition.Visual examination revealed that there is a hair like fiber sealed inside the inner pouch.The complaint failure mode was confirmed, and the device was confirmed to be manufactured out of specification.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 revealed no relevant nonconformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_ce_angio88_rev6] ¿angiography catheters,¿ provides the following information to the user related to the reported failure mode: ¿how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, inspection of the returned device, and the results of the investigation, cook has concluded that quality control deficiency contributed to this incident.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.

• Brand Name: TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Common Device Name: 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: 13560502
• Report Number: 1820334-2022-00260
• Device Sequence Number: 14493778
• Product Code: DQO
• UDI-Device Identifier: 00827002067493
• UDI-Public: (01)00827002067493(17)241215(10)14401405
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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
• Operator of Device: Other
• Device Expiration Date: 12/15/2024
• Device Model Number: N/A
• Device Catalogue Number: HNB5.0-38-40-P-NS-KMP
• Device Lot Number: 14401405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown