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

Catalog Number CODA-2-9.0-35-120-32

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Customer (person): postal code: (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 lp balloon catheter leaked due to a pinhole during an endovascular aneurysm repair (evar) procedure.Following placement of competitor main body and leg grafts, the physician intended to use the coda balloon for touch-up through a competitor sheath.However, contrast media was noted to be leaking from the balloon.Upon removal from the patient, a pin hole was noted in the material.Another same device was used to complete the procedure with no adverse effects to the patient.It was also reported that there was not any notable calcification or tortuosity within the access vessels.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.(b)(6) medical center informed cook on 28jul2021 of an incident involving a coda lp balloon catheter (coda-2-9.0-35-120-32) lot # 13689124.During an evar procedure while using competitor devices, the physician used a coda lp balloon catheter through the competitor¿s sheath for touch-up.While doing this the physician discovered leakage of contrast media from the balloon.The physician then withdrew the balloon from the patient and discovered a pin hole in the balloon material.The device was replaced with another coda lp balloon catheter to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complainant did not return the complaint device to cook for investigation and no imaging was provided for procedural review.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 dhrs for the reported complaint device lot and the subassembly work orders revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.Evidence provided by the complaint facility, device history record, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook also reviewed product labeling.The device was packaged with ifu, t_codalp_rev3 ¿coda and coda lp balloon catheters,¿ which provides the following information to the user related to the reported failure mode: ¿device description the balloon is manufactured from a compliant polyurethane material.Particular care should be taken in handling the balloon to prevent damage.The balloon will inflate to the indicated size parameters when utilizing proper volume recommendations.Warnings do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.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.The coda 40 mm balloon catheter should not be used for dilation of vascular prostheses in iliac or other non-aortic vessels.Injury to vessel wall and/or rupture may occur.The coda 40 mm balloon catheter should not be used in vessels less than 24 mm in diameter.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.Balloon inflation volume: do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over-inflation of balloon may result in: rupture of balloon.Balloon preparation note: balloon and balloon lumen of the coda and coda lp balloon catheters contain air.The air must be removed from the balloon and balloon catheter prior to insertion using standard technique.1.Remove protective balloon sleeve.2.Prepare balloon lumen with standard 3:1 saline and contrast mixture, to stopcock on balloon lumen.A.Attach syringe, with appropriate amount of 3:1 saline and contrast mixture, to stopcock on balloon lumen.B.Purge all air from balloon in standard fashion.C.Completely deflate balloon and close stopcock.3.To increase ease of insertion, balloon may be lubricated with a thin layer of sterile, biocompatible lubricant.Balloon introduction and inflation 4.Inflate balloon with standard 3:1 saline and contrast mixture using a 20 cc or larger syringe.Adhere to recommended balloon inflation volumes.5.If balloon pressure is lost and/or balloon rupture occurs, deflate the balloon and remove balloon and sheath as a unit.Note: care should be taken to monitor balloon manipulations and inflation using fluoroscopy at all times.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 available information, no device return, and the results of the investigation, a definitive cause cannot be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 LP BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12253167
• MDR Text Key: 265845928
• Report Number: 1820334-2021-01898
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002038315
• UDI-Public: (01)10827002038315(17)240114(10)13689124
• Combination Product (y/n): N
• PMA/PMN Number: K150970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 13689124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GORE DRYSEAL SHEATH; GORE LEG GRAFT(S); GORE MAIN BODY GRAFT