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

Model Number N/A

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

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 ruptured during a stent graft placement procedure.During a procedure to treat an iliac artery aneurysm, a competitor graft was initially placed.The patient's access vessel was approximately 7mm in size with no strong calcification or tortuosity.Following graft placement, a coda balloon was to be used to seal the graft in place in the patient's common iliac artery to their external iliac artery.The balloon was reported to have "inflated to some degree but didn't inflate any further".Consequently, the balloon was deflated without issue and replaced with another like device from a different lot to complete the procedure.A photo of the device shows a visible tear on the proximal side of the balloon.No adverse effects to the patient have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5 investigation - evaluation hakodate municipal hospital informed cook on (b)(6) 2020 of an incident involving a coda lp balloon catheter (coda-2-9.0-35-120-32) from lot 13282358.The balloon reportedly ruptured during a stent graft placement procedure on (b)(6) 2020.Communication with the user facility clarified that no difficulty was noted during the device insertion.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used coda balloon was returned to cook for evaluation.A visual inspection found that the device was ruptured longitudinally.Cook has concluded that the device was manufactured to specification.Additionally, 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 device history record (dhr) for the reported complaint device lot (13282358) revealed no recorded non-conformances relevant to the reported failure mode.As 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 have been received from the field, it was concluded that there is no evidence that nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, [t_codalp_rev3] ¿coda and coda lp balloon catheters,¿ provides the following information to the user 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, inspection of the returned product, and the results of the investigation, a definitive root cause was unable to be established but could potentially be traced to component failure.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.

Event Description

In additional information received on (b)(6)2021, it was reported that diluted contrast media was used to inflate the balloon.No difficulties were noted during insertion of the device.

• 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: 10771653
• MDR Text Key: 214371791
• Report Number: 1820334-2020-01992
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002038315
• UDI-Public: (01)10827002038315(17)230702(10)13282358
• 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
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 13282358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASAHI INTECC / EGS-35-30J-260P (GUIDE WIRE).; GORE / PLC-121000J.