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

Model Number N/A

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

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 ruptured during an evar procedure.Following implantation of three cook grafts, the user attempted to expand the main body, overlap region, and leg fixation site using a coda lp balloon catheter.However, it was noted that the balloon was not inflating.Upon removing the device from the patient, it was found to be "damaged and ruptured".Another same device was used to complete the procedure without any adverse effects to the patient.It was also reported that the patient's anatomy was within the recommendations listed in the instructions for use (ifu) provided with the implanted devices.Additional information regarding the device and event has been requested but is currently unavailable.

Manufacturer Narrative

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

Event Description

In additional information received on 25feb2021, it was reported that a standard 3:1 saline and contrast mixture was used to inflate the balloon.The failure was noticed during a subsequent attempt (not the first attempt) to inflate in the distal fixation site of the ipsilateral limb.

Event Description

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

Manufacturer Narrative

The complaint facility toyohashi heart center informed cook of an incident involving a coda lp balloon catheter (coda-2-9.0-35-120-32) from lot 13342337.The balloon reportedly ruptured during an evar procedure on 10feb2021.Communication with the user facility clarified that the difficulty was experienced while ballooning at the distal fixation site of the ipsilateral limb and that the patient anatomy was within the parameters stated in the ifu.The patient reportedly experienced no adverse effects as a result of this incident, no additional harm was reported.A review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) found 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 the affected product is safe and effective for its intended use.A review of the device history record (dhr) for lot 13342337 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there have been no other complaints associated with this lot number.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field and that the complaint lot was manufactured to current specifications.The instructions for use (ifu), provides the following information related to the reported failure mode: warnings.When used to expand a vascular prosthesis, the balloon radiopaque markers should remain within the prosthesis.Maximum inflation volume: 30 cc.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the failure could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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
• MDR Report Key: 11329933
• MDR Text Key: 266301316
• Report Number: 1820334-2021-00332
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002038315
• UDI-Public: (01)10827002038315(17)230803(10)13342337
• Combination Product (y/n): N
• PMA/PMN Number: K150970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 13342337
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZIMB-32-108; ZISL-13-77; ZISL-16-77
• Patient Age: 81 YR