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 Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Concomitant products: lombard medical aortfix; gore excluder leg (qty.2); gore dryseal sheath (12fr); medtronic reliant balloon catheter.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 was unable to be inflated during an evar procedure, potentially due to a hole in the balloon material.In order to treat the patient's aortic aneurysm, a competitor graft was placed below the arteries along with one competitor leg graft in each iliac artery.Ballooning was initially attempted with another device unsuccessfully, which is reported under mfg.Report reference #: 1820334-2020-01328.Consequently, ballooning was attempted again with this device.The device was inserted through a competitor 12fr.Sheath to seal the proximal neck, junction of the leg, and the distal sealing site.During advancement of the balloon, the physician felt slight resistance at the femoral area, which was confirmed to have calcification.The physician advanced the balloon into the target site and attempted to inflate the balloon, but found that the device was unable to be inflated.Following two failed ballooning attempts with two separate devices, the physician advanced the sheath into one of the deployed leg grafts to avoid the calcification (as the physician attributes the failed attempts to the calcification).A competitor balloon catheter was placed into the sheath and the target sites were successfully sealed.The procedure was able to be completed with no adverse effects to the patient.

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

Upon receipt of the device on 04aug2020, multiple pin holes were observed in the device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: section c.Investigation - evaluation.(b)(6) medical center informed cook on 09jul2020 of an incident involving a coda lp balloon catheter (coda-2-9.0-35-120-32) from lot 13197071.It was reported that two balloons could not be inflated during an evar procedure on (b)(6) 2020.The other balloon is reported under mdr ref.#(b)(4).It was communicated that the user believes that calcification in the femoral artery was the cause of the balloon damage.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 and functional test of the returned device, was performed during the investigation.One used device was returned to cook for evaluation.Upon visual inspection, biomatter was noted on the device.No visible damage to the catheter portion of the device was noted.The balloon was inflated, which revealed multiple pin holes.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 dhr for the reported complaint device lot (13197071) revealed no recorded non-conformances relevant to the failure mode.A database search found no other events associated with the reported device lot.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 that 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 ¿ 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.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 fig.1.Over-inflation of balloon may result in: ¿ damage to vessel wall and/or vessel rupture.¿ rupture of balloon.Maximum inflation volumes: for rpn coda-2-9.0-35-120-32, max.Volume is 30 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: 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.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.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 for this event was not traced to the device but rather to the patient's condition.It is likely that the calcification in the patient's vessel caused the pinholes.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

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

• 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: 10298794
• MDR Text Key: 241617784
• Report Number: 1820334-2020-01329
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002038315
• UDI-Public: (01)10827002038315(17)230518(10)13197071
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 13197071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1