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

Model Number	G08153
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned.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, upon opening the package, the "near end tip" of a torcon nb advantage angiographic catheter was broken.The device did not make patient contact.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested, but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, upon opening the package, the "near end tip" of a torcon nb advantage angiographic catheter was kinked and cracked.The device did not make patient contact.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures of the device were conducted during the investigation.The device was not returned for investigation; no physical evaluation was performed.A document-based investigation evaluation was performed.A review of the device history record showed one potentially failure-related nonconformance.All affected product was identified and scrapped prior to further processing.One additional complaint was reported for this product lot.Cook could not confirm that the two devices exhibit the same failure.No further complaints were reported for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.No gaps were discovered in the manufacturing instructions, specifications, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which state, ¿upon removal from package, inspect the product to ensure no damage has occurred." based on the information available, investigation has concluded that a cause for this event could not be established.A capa was previously initiated and remains open to further investigate this failure mode.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 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 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 or unavailable.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.
Event or Problem Description
Additional information was received 06may2020.The device was kinked and displayed a crack.The device was replaced to successfully complete the procedure.

• 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: 9916143
• Report Number: 1820334-2020-00735
• Device Sequence Number: 2764189
• Product Code: DQO
• UDI-Device Identifier: 00827002081536
• UDI-Public: (01)00827002081536(17)221025(10)10089910
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2020

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: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: G08153
• Device Catalogue Number: HNB5.0-38-100-P-NS-MPA
• Device Lot Number: 10089910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 06/18/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/21/2020; 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1