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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during an endovascular aneurysm repair that a coda balloon catheter was used on a male patient to seal the stent graft neck to the vessel.The physician attempted the third inflation of the balloon and when performing the ballooning at the distal side, the balloon ruptured.There was no information provided regarding the direction of the balloon rupture.It was reported that the physician performed the procedure while checking the (balloon volume) chart.A second coda balloon catheter was used to complete the procedure.There have been no adverse effect to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: one used/damaged coda balloon catheter was received for evaluation along with a 35-ml syringe.Visual inspection of the device noted the balloon was separated and torn at the shaft of the catheter tip.There was some liquid in the syringe.Functional testing determined the balloon could not be pressurized.Leaking occurred at the area of separation.The customer report has been confirmed.Balloon bursts can be caused by over inflation, pulling on the balloon while inflated, ballooning in calcification, ballooning partially outside of a vascular prosthesis, or manufacturing issues.Based on the available information a definitive root cause of the balloon bursting cannot be established.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against lot # 7489971.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6538282
• Report Number: 1820334-2017-00730
• Device Sequence Number: 1642284
• Product Code: DQY
• UDI-Device Identifier: 00827002530249
• UDI-Public: (01)00827002530249(17)191205(10)7489971
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: N/A
• Device Catalogue Number: CODA-2-10.0-35-120-32
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1