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

Model Number N/A

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: mobile: (b)(6).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 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 or that a death or serious injury occurred; nor is it admission 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

It was reported to cook that the balloon of a coda balloon catheter had ruptured.The patient had been diagnosed with a thoracic aortic aneurysm and underwent thoracic endovascular aortic repair.After the implantation of the cook zenith alpha thoracic endovascular graft proximal component and the zenith alpha thoracic endovascular graft distal component, the cook coda balloon was deflated and then inserted from the right via an artificial blood vessel in the access route.It was then advanced through the outer sheath of the zenith alpha thoracic endovascular graft distal component.Some resistance was felt during the insertion into the sheath, however, the cook coda balloon catheter was able to be advanced to the target site.Ballooning was performed in the proximal graft.Next balloon dilation was attempted in the distal flexure of the zenith alpha thoracic endovascular graft distal component.The balloon was expanded by using a 50 cc syringe.Pressure was exerted just until the balloon became a bale shape (oval shape) and the exact volume and pressure were unknown due to being inflated by feeling with the hands.The flexion in the distal part of the zenith alpha thoracic endovascular graft distal component was reported to be "strong." the dilation was unsuccessful despite no sensation of the balloon rupturing when dilated inside the stent graft.The cook coda balloon was taken out of the patient and was discovered to be ruptured.Another cook coda balloon was used to complete the procedure.The case was completed without any further issues.It was also noted that the successful inflation took place at the proximal sealing (1~2 stents from the edge), and the unsuccessful inflation took place at the distal sealing (1~2 stents from the edge).There was no calcification in the area of the ballooning of the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d9 (product received on) correction: h6 (annex a) 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 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 or that a death or serious injury occurred; nor is it admission 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

The device was returned for investigation.During the preliminary device failure, it was discovered that a pin hole was present in the balloon and leaked.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.The patient had been diagnosed with a thoracic aortic aneurysm and underwent thoracic endovascular aortic repair.After the implantation of the cook zenith alpha thoracic endovascular graft proximal component and the zenith alpha thoracic endovascular graft distal component, the cook coda balloon was deflated and then inserted from the right via an artificial blood vessel in the access route.It was then advanced through the outer sheath of the zenith alpha thoracic endovascular graft distal component.Some resistance was felt during the insertion into the sheath, however, the cook coda balloon catheter was able to be advanced to the target site.Ballooning was performed in the proximal graft.Next balloon dilation was attempted in the distal flexure of the zenith alpha thoracic endovascular graft distal component.The balloon was expanded by using a 50 cc syringe.Pressure was exerted just until the balloon became a bale shape (oval shape) and the exact volume and pressure were unknown due to being inflated by feeling with the hands.The flexion in the distal part of the zenith alpha thoracic endovascular graft distal component was reported to be "strong." the dilation was unsuccessful despite no sensation of the balloon rupturing when dilated inside the stent graft.The cook coda balloon was taken out of the patient and was discovered to be ruptured.Another cook coda balloon was used to complete the procedure.The case was completed without any further issues.Reviews of the documentation, including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used device was returned for evaluation.A leak test was performed and confirmed a pinhole near the proximal bonded side of the balloon.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 device history record (dhr) for the device lot found four nonconformances, in which all four were properly identified, scrapped and not replaced.The remaining lots were sent to quality control for 100% inspection, leaving no indication that nonconforming product was shipped.It should be noted that there were no other complaints associated with the final product lot number.Cook was also able to review product labeling.The product ifu, t_coda2-_rev6 ¿coda balloon catheter,¿ provides the following information to the user related to the reported failure mode: "warnings ¿ do not exceed maximum inflation volume.Rupture of balloon may occur.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 ¿ 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 in vessels less than 24 mm in diameter.¿ when used to expand a vascular prosthesis, the balloon radiopaque markers should remain within the prosthesis, precautions ¿ this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides be employed.¿ always manipulate catheter using fluoroscopic control.¿ use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate balloon.¿ always monitor balloon inflation using fluoroscopic control potential adverse events ¿ vessel dissection, perforation, rupture or injury balloon inflation volume do not exceed maximum inflation volume.Rupture of balloon may occur.Adhere to balloon inflation volume parameters as shown below.Over-inflation of balloon may result in damage to vessel wall and/or vessel rupture.Maximum inflation volumes catheter size max.Volume coda-2-10.0-35-120-40 40 cc balloon preparation note: balloon and balloon lumen of the coda balloon catheter contain air.The air must be removed form balloon and balloon catheter prior to insertion using standard technique.Caution: if the coda balloon catheter is being utilized to expand a vascular prosthesis, use the radiopaque markers to ensure that the entire balloon is positioned within the prosthesis.Balloon deflation and withdrawal 1.Completely deflate the balloon using an appropriately sized syringe.Allow adequate time for the balloon to deflate.2.Deflate the balloon by pulling vacuum on the inflation syringe.3.Maintain vacuum on the balloon and withdraw the catheter.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues remove balloon and sheath as a unit.How supplied sterilized by ethylene oxide gas in peel-open packages.Intended for on-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.Inspection of device visually inspect the device thoroughly including all levels of the packaging to verify that there is no damage prior to use.Visually inspect and confirm that the integrity of the sterile barrier has not been compromised in any way." evidence provided by the complaint facility, device failure analysis, dhr, complaint history, and manufacturing documents 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.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive cause for the failure could not be established.While the customer indicated there was difficulty advancing the sheath, the balloon was still able to be inflated at the proximal end after being advanced.There was no calcification at the site of inflation.The balloon was inflated with a 50cc syringe, the exact volume and pressure was unknown.While over inflation of the balloon could be a contributing factor this could not be determined definitively.The appropriate personnel have been notified.Per the 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.

Event Description

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

• Brand Name: CODA 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: 18276759
• MDR Text Key: 329929270
• Report Number: 1820334-2023-01641
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-10.0-35-120-40
• Device Lot Number: 14839178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/09/2024; 02/09/2024
• Supplement Dates FDA Received: 01/11/2024; 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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: COOK TSCMG-35-300-LESDC, LOT E4466423.; COOK ZTA-D-42-204-W1, LOT E4341516.; COOK ZTA-P-36-209-W1, LOT E4456541.