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

Model Number	G36042
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility reported that the (b)(6) patient underwent an endovascular aneurysm repair (evar).The patient anatomical form was suitable for the procedure and the procedure was performed as labeled.Another manufacturer's guide wire was used.Before final angiography, the coda balloon catheter was used to seal the proximal side, but it ruptured during use.Another coda balloon catheter was used instead to continue the procedure.There has been no adverse effect to the patient reported.The patient has been reported to be ¿recovered¿.
Additional Manufacturer Narrative
Additional information: patient identifier, concomitant medical products: a medicos hirata/egoist 260mm guidewire was also used during this procedure.Investigation ¿ evaluation: a document-based investigation has been performed which included review of complaint history, the device history record, documentation, drawings, instructions for use, quality control data, and specifications.Visual inspection of the returned device was also conducted.One used coda balloon stopcock attached to y fitting was returned.The balloon is ruptured radially.The shaft appears undamaged.The distal balloon is folded back on itself 5 mm.Balloon bonds are intact with good transitions.The tip of device is not damaged.The distal portion of the balloon was unfolded and pulled back to the original position as manufactured.The entire balloon was still attached, indicating no portion separated in the patient when the balloon ruptured.A review of the device history record found no non-conformances noted.A review of complaint history revealed no other complaints from external customers on this lot.Each coda balloon device is shipped with instructions for use (ifu), which specifies the maximum balloon inflation volume and provides instructions on balloon preparation, inflation, deflation and withdrawal.No information was provided regarding patient anatomy.The pressure and volume of balloon inflation was reported as unknown.Information about the ballooning part of the procedure such as technique or resistance felt was requested but not provided.A medicos hirata/egoist 260mm guide wire was used for this procedure.Imaging and the sizing chart are not available.It was unknown if the patient was on anticoagulants.Balloon rupture can be caused by over-inflation, pulling on the balloon while inflated, patient vessel calcification, ballooning partially outside of a vascular prosthesis, or manufacturing issues.The qc specification, manufacturing instructions, and design history files were reviewed and no evidence was found that the device was manufactured out of specification and no non-conformances were noted in the manufacturing department.No damage was reported during the preparation of the device therefore.Based on the available information, the likely causes of the balloon rupture were improper ballooning technique, over-inflation of the balloon, or patient anatomy related (such as calcification).The root cause for this complaint will be documented as undetermined without having the additional information regarding patient anatomy (besides being stated to be suitable for the procedure), volume and pressure of balloon inflation, imaging, sizing and position of the inflated balloon.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed 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: 7005602
• Report Number: 1820334-2017-03496
• Device Sequence Number: 13735866
• Product Code: DQY
• UDI-Device Identifier: 00827002360426
• UDI-Public: (01)00827002360426(17)200620(10)8003322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: G36042
• Device Catalogue Number: CODA-10.0-35-100-32
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR