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

Model Number	G08895
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 or Problem Description
As reported, during inspection within a distribution facility, an unknown particle was observed inside the primary package of a torcon nb advantage angiographic catheter.The device did not make contact with any patient.
Additional Manufacturer Narrative
Initial report: as reported, during inspection within a distribution facility, an unknown particle was observed inside the primary package of a torcon nb advantage angiographic catheter.The device did not make contact with any patient.Investigation ¿ evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; however, photos were provided of the device.From the photos, a foreign particle can be confirmed within the sealed packaging.A document-based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.An ifu is provided with this device which states ¿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 information provided and no product returned, cook has concluded that a quality control deficiency likely led to the reported event.Though the device was not returned, the packaging appears to be sealed with a small unknown fiber.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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 or Problem 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
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10105508
• Report Number: 1820334-2020-01036
• Device Sequence Number: 16821091
• Product Code: DQO
• UDI-Device Identifier: 00827002088955
• UDI-Public: (01)00827002088955(17)221108(10)10124401
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: No Information
• Device Expiration Date: 11/08/2022
• Device Model Number: G08895
• Device Catalogue Number: HNB5.0-38-100-P-NS-DAV
• Device Lot Number: 10124401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1