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

Catalog Number CODA-2-10.0-35-140-46

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a coda balloon catheter would not inflate prior to use on the patient.No patient contact was made and no damage to the device/device packaging was reported.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation: the complainant, (b)(6) hospital located in canada, informed cook on 06apr2020 of an incident that occurred on 07dec2018 involving a coda balloon catheter with rpn coda-2-10.0-35-140-46 from lot 8991576.Prior to a procedure, the complaint device was tested for inflation.The device failed and the balloon would not inflate.No damage was noted to the device or device packaging.No patient contact was made.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (8991576) revealed no relevant non-conformances.A database search did not identify any other reported events associated with the complaint device lot.As there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no recorded non-conformances, and no other lot-related complaints received from the field, cook has concluded that the device was manufactured to specification and that there is no evidence that non-conforming product exists either in house or in the field.Cook also reviewed product labeling.The product instructions for use (ifu), [t_coda46_rev0] ¿coda® and coda® lp balloon catheters¿, provides the following information to the user related to the reported failure mode: ¿warnings do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in figs.1 and 2.Over-inflation of balloon may result in: damage to vessel wall and/or vessel rupture.Rupture of balloon.Do not use a pressure inflation device for balloon inflation.Do not use a power injector for injection of contrast medium through distal lumen.Rupture may occur.Precautions: use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate balloon.Always monitor balloon inflation using fluoroscopic control.Product recommendations: balloon inflation volume do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in figs.1 and 2.Over-inflation of balloon may result in: damage to vessel wall and/or vessel rupture.Rupture of balloon.Maximum inflation volumes.For rpn coda-2-10.0-35-140-46, max.Volume is 60 cc.Instructions for use: balloon preparation: note: balloon and balloon lumen of the coda and coda lp balloon catheters contain air.The air must be removed from balloon and balloon catheter prior to insertion using standard technique.2.Prepare balloon lumen with standard 3:1 saline and contrast mixture as follows: attach syringe, with appropriate amount of 3:1 saline and contrast mixture, to stopcock on balloon lumen.Purge all air from balloon in standard fashion.Completely deflate balloon and close stopcock.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.¿ based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Based on the reported information, it is likely that the balloon ¿failed¿ during testing and did not inflate due to a pinhole; however, this cannot be confirmed without additional information or device return.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.

• Brand Name: CODA BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9981939
• MDR Text Key: 199991167
• Report Number: 1820334-2020-00854
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002237732
• UDI-Public: (01)10827002237732(17)210702(10)8991576
• Combination Product (y/n): N
• PMA/PMN Number: K122917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Catalogue Number: CODA-2-10.0-35-140-46
• Device Lot Number: 8991576
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1