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

Model Number	G05955
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Non-healthcare professional.Pma/510(k) number = pre-amendment.Device evaluation has begun; however, a conclusion is not yet available.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, the user opened the package and removed the torcon nb advantage angiographic catheter when the head of the catheter fell.Off the tip was described as broken.This device did not make patient contact.The user changed to another torcon nb advantage angiographic catheter and successfully completed the procedure.No patient adverse effect was reported.Upon preliminary visual inspection by the manufacturer, it was noted the tip is broken off.The missing tip piece was not returned for investigation.
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
Investigation/evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, manufactures instructions, quality control, specification, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that biomatter was present on the proximal hub and throughout the shaft.A portion of the distal tip was missing.The surface appeared scraped and compressed at the distal tip on the shaft from 5cm to 5.5cm proximal to the distal tip, and 11.5cm to 12.5cm proximal to the distal tip.Length of distal tip after the bond site was 0.4cm.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.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.

• 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: 7993740
• Report Number: 1820334-2018-03220
• Device Sequence Number: 1488067
• Product Code: DQO
• UDI-Device Identifier: 00827002059559
• UDI-Public: (01)00827002059559(17)210511(10)8789427
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 01/10/2019

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: 05/11/2021
• Device Model Number: G05955
• Device Catalogue Number: HNB5.0-38-80-P-NS-C2
• Device Lot Number: 8789427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1