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

Model Number	G53024
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a patient underwent an endovascular aneurysm repair (evar).The coda balloon catheter was used to perform touch-up ballooning, however the balloon ruptured during first inflation at proximal neck.Another coda balloon catheter was used to complete the procedure without problems.It was confirmed that when the balloon ruptured, it was inflated about 25 ml ~ 30 ml.There have been no adverse effects to the patient reported.No additional procedure was required due to the reported issue.The patient¿s current status has been reported as ¿recovered¿.
Additional Manufacturer Narrative
Evaluation / investigation.A visual inspection of the returned device was conducted.In addition, a review of the device history record, instructions for use, manufacturing instructions, and quality control data was performed.The device was returned used and a device analysis was performed.The shaft of the device appeared undamaged.The balloon was torn along the entire length of the balloon.The balloon bonds were found to be passing specification.The catheter was verified to be free of damage.The balloon displayed evidence of a full length longitudinal rupture.The device history record was reviewed and no nonconformances related to the reported failure mode were noted.A review for additional complaints for this device lot revealed this is only reported complaint associated to the complaint lot number 8388128.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.This device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions.Per the ifu, upon removal from package, inspect the product to ensure no damage has occurred.Do not exceed maximum inflation volume.Rupture of balloon may occur.The balloon is constructed of heat-sensitive material.Do not heat or attempt to shape the catheter tip.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate balloon.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.The maximum inflation volume listed in the ifu for this rpn is 34 cc's.Balloon rupture can be caused by over-inflation, moving the balloon while inflated, patient vessel calcification, and/or inflating the balloon partially outside of the vascular prosthesis.The physician noted that between 25ml to 30ml of media was injected before the rupture occurred.This amount is less than the maximum inflation volume of 34 ml listed in the ifu for this device.There was no evidence to suggest over-inflation of the balloon or inflation of balloon outside of the vascular prosthesis based on information provided by the customer.No imaging or information was provided regarding the presence or not of calcification in the patient's anatomy.No information was given by the customer to suggest that movement of the balloon occurred while the balloon was inflated.Based on the information provided and the lack of imaging, a definitive cause could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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.Evaluation / investigation.A visual inspection of the returned device was conducted.In addition, a review of the device history record, instructions for use, manufacturing instructions, and quality control data was performed.The device was returned used and a device analysis was performed.The shaft of the device appeared undamaged.The balloon was torn along the entire length of the balloon.The balloon bonds were found to be passing specification.The catheter was verified to be free of damage.The balloon displayed evidence of a full length longitudinal rupture.The device history record was reviewed and no nonconformances related to the reported failure mode were noted.A review for additional complaints for this device lot revealed this is only reported complaint associated to the complaint lot number 8388128.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.This device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions.Per the ifu, upon removal from package, inspect the product to ensure no damage has occurred.Do not exceed maximum inflation volume.Rupture of balloon may occur.The balloon is constructed of heat-sensitive material.Do not heat or attempt to shape the catheter tip.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate balloon.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.The maximum inflation volume listed in the ifu for this rpn is 34 cc's.Balloon rupture can be caused by over-inflation, moving the balloon while inflated, patient vessel calcification, and/or inflating the balloon partially outside of the vascular prosthesis.The physician noted that between 25ml to 30ml of media was injected before the rupture occurred.This amount is less than the maximum inflation volume of 34 ml listed in the ifu for this device.There was no evidence to suggest over-inflation of the balloon or inflation of balloon outside of the vascular prosthesis based on information provided by the customer.No imaging or information was provided regarding the presence or not of calcification in the patient's anatomy.No information was given by the customer to suggest that movement of the balloon occurred while the balloon was inflated.Based on the information provided and the lack of imaging, a definitive cause could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: CODA BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7278108
• Report Number: 1820334-2018-00351
• Device Sequence Number: 2379163
• Product Code: DQY
• UDI-Device Identifier: 00827002530249
• UDI-Public: (01)00827002530249(17)201120(10)8388128
• Combination Product (Y/N): N
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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 Model Number: G53024
• Device Catalogue Number: CODA-2-10.0-35-120-32
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)