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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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 or Problem Description
It was reported that two coda lp balloons ruptured during an endovascular aneurysm repair procedure.The patient was considered suitable for this procedure, although had vessel calcification and slight angulation at or near the inflation site.After a stent graft was placed by right approach, ballooning was performed in the proximal site of the stent graft.The first balloon ruptured "on the distal side of the balloon" after the second or third ballooning.The second balloon also ruptured at the proximal site of the stent graft, this time on first ballooning.The contrast to saline ratio for inflation of the balloons was 10:20 and the volume used for both devices was approximately 20/25 ml.No inflation device was utilized for inflation of either balloon.The procedure was completed with another manufacturer's balloon device.There have been no adverse effects to the patient reported.The first balloon that ruptured is captured in the report with patient identifier (b)(6) (this report).The second balloon that ruptured is captured in the report with patient identifier (b)(6).
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation (b)(6) center (b)(6) hospital informed cook on 06jul2022 of an event with rpn: coda-2-9.0-35-100-32 (product lot 14392531).A patient underwent an evar procedure on (b)(6) 2022 with medicos hirata's stent graft aorfix by right approach.The physician performed ballooning with coda-2-9.0-35-100-32 product lot 14392531.However, the balloon ruptured at the second or third ballooning.Therefore, the balloon was replaced with a second coda-2-9.0-35-100-32 product lot 14442398.The second coda balloon ruptured at the first ballooning site and the physician replaced with another manufacturer's device to complete the procedure successfully.The inflation volume of the balloon used during the procedure was 20-25cc.Contrast 10cc + saline 20cc ration was used to inflate the balloon during the procedure.The patient was considered suitable for the procedure.It was reported there was slight angulation and vessel calcification at the inflation site.There were no adverse effects reported to the patient due to this occurrence.On 02feb2017 (160 days pre-procedure), pre-procedure imaging revealed a stable type iv thoracoabdominal aortic aneurysm with mild iliac angulation.The location of start of aneurysm was unknown.The maximum aneurysm diameter was 85.0 mm.All branch vessels (celiac, sma, right and left renal) were patent, and there were no renal infarcts.The first balloon that ruptured is captured in this report (b)(4).The second balloon that ruptured is captured in report (b)(4).Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.Physical examination of the device showed two pin holes on the balloon.One hole was near the top of the balloon.The second hole was on the opposite side of the balloon, approximately in the middle of the balloon.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 dhrs for the reported complaint device lot two non-conformances.There were two nonconformance¿s reported but they were scrapped and not replaced prior to further processing.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The device was packaged with ifu t_codalp_rev3.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.¿warnings ¿ do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over-inflation of balloon may result in: o damage to vessel wall and/or vessel rupture.O 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 the 24 mm diameter.Potential adverse events ¿ vessel dissection, perforation, rupture, or injury 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 catheter size max.Volume coda-2-10.0-35-120-40 40 cc coda-2-9.0-35-100-32 30 cc coda-2-9.0-35-120-32 30 cc balloon introduction and inflation ¿ caution: prior to introduction, determine the amount of standard 3:1 saline and contrast mixture needed to inflate the balloon to the desired inflation diameter.Refer to the balloon inflation parameters chart in fig.1.Over-inflation of the balloon may result in damage to vessel wall and/or vessel rupture.¿ 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.¿ after review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Based on the available information, inspection of the returned device, and the results of the investigation, a definitive conclusion could not be established.It was reported that there was slight angulation and vessel calcification at the inflation site which may have contributed to this event, though this cannot be confirmed without additional information.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
• Common Device Name: 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: 15075124
• Report Number: 1820334-2022-01248
• Device Sequence Number: 5515659
• Product Code: DQY
• UDI-Device Identifier: 00827002038325
• UDI-Public: (01)00827002038325(17)241203(10)14392531
• Combination Product (Y/N): N
• PMA/510(K) Number: K150970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2024
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-100-32
• Device Lot Number: 14392531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AORFIX MAIN BODY, MB-24-96-80-12/LOT:DL0101771-1; CONTRALATERAL LEG, CL-73-14 LOT:DM0100324-1
• Patient Sex: Unknown