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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2017
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 and/or completion of the investigation.
Event or Problem Description
An international customer reported that a patient underwent abdominal aortic aneurysm (aaa) repair using another manufacturer's graft stent.After placing the stent, the physician removed the air from the cook coda balloon catheter for touch-up.At this time, no problem on the balloon was observed, so he inserted it into the right femoral through another manufacturer¿s sheath (20fr) and attempted to inflate the balloon with 10cc for touch-up on the contralateral leg.The balloon was inflated within the stent graft.However the balloon would not inflate and leaked contrast media.He replaced it with another coda balloon catheter from a different lot to complete the procedure.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation: evaluation: a review of dimensional verification, device history record, manufacturing instructions, instructions for use (ifu), quality control data, and visual inspection/functional testing of the returned device was conducted during the investigation.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Visual inspection and functional testing of the returned device was performed.An examination revealed no damage to the catheter shaft.Transition and integrity of the balloon bonds were per specification as well as the diameter and length of the catheter.A syringe with water was used and confirmed a hole was present in the balloon.It is possible that the stents on the graft could have damaged the balloon and although details of the patient's anatomy was not provided; contact with calcification could have also damaged the balloon.Without additional information, images, or a representative of the competitor graft to test, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.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: 6729018
• Report Number: 1820334-2017-01724
• Device Sequence Number: 1371179
• Product Code: DQY
• UDI-Device Identifier: 00827002530249
• UDI-Public: (01)00827002530249(17)200316(10)7753700
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 06/28/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67