MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G26890
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation = non-healthcare professional.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 initially reported that the material of an atb advance balloon catheter was broken.Further detail was provided stating that a fracture was identified on the complaint device.This was observed by the "sector responsible for storing the product," and was noticed while the device was in its packaging.The device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos were provided by the customer although the images are not clear enough to draw conclusions from about the condition of the device.It appears that the section in the photograph is the balloon catheter shaft.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 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.The device is also provided with instructions for use (ifu) which states as a step for balloon preparation, "2.Upon removal from package, inspect the catheter to ensure no damage has occurred during shipping." based on the information provided and no product returned, investigation has concluded a cause for this event cannot 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 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.

• Brand Name: ATB ADVANCE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8487306
• Report Number: 1820334-2019-00799
• Device Sequence Number: 1928806
• Product Code: DQY
• UDI-Device Identifier: 00827002268906
• UDI-Public: (01)00827002268906(17)200516(10)8887125
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033875
• 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): 04/24/2019

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: 05/16/2020
• Device Model Number: G26890
• Device Catalogue Number: ATB5-35-80-10-4.0
• Device Lot Number: 8887125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1