MAUDE Adverse Event Report: COOK INC CODA LP BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter also sent report to fda: unknown.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 a coda lp balloon catheter was used in an unknown patient for a endovascular aneurysm repair (evar).After placing another manufacturer¿s stent graft, the physician attempted to perform ballooning with a coda lp balloon catheter.As reported, ¿the device could not be inflated though the physician was using the device following the ifu¿.The user reports changing out the stopcock but was unsuccessful in inflating the balloon.Upon investigation of the hub, user noted a crack and leaking which leaked during flushing.The report further states the procedure was completed with another coda lp balloon catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
There is no new event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.According to the customer, the device will not be returned due to infectious disease.Therefore, a device failure analysis could not be performed.A photograph of the device was provided.A document based investigation was conducted including a review of the photo, complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.The complainant did not return the complaint device for investigation.However, the complainant provided an image of the manifold assembly of the complaint device.From the provided image, no biomatter is noted on the device.In the provided image, a red circle was drawn to indicate the failure occurred on the balloon lumen of the manifold assembly.The picture is a little blurry and there is no sign of an obvious crack on the balloon lumen.Therefore, the complaint cannot be confirmed based on the provided image.A review of the device history records found there were no non-conformances related to the reported failure mode.A review of complaint history records revealed no additional complaints have been received on the complaint device lot.The device is supplied with the instructions for use (ifu) which provides the following information to the user related to the reported failure mode: -the ¿distal¿ lumen extends the length of the catheter and is used for placement over wire guides.The ¿balloon¿ lumen is used to inflate and deflate the balloon.Intended use: the coda and coda lp balloon catheters are intended for temporary occlusion of large vessels, or to expand vascular prostheses.Instructions for use: -note: ¿balloon¿ lumen is for inflation and deflation of balloon.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.Without the returned device and the blurry image provided, findings of this investigation revealed no evidence to suggest the device was manufactured out of specifications.The investigation conclusion for this complaint is cause not established.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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: CODA LP BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8546919
• Report Number: 1820334-2019-00993
• Device Sequence Number: 1731077
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)211227(10)9406751
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 12/27/2021
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 9406751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1