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

Model Number	G03831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/23/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: gore excluder stent graft.Tscmg-35-260-7-les-jp guidewire.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
It was initially reported on (b)(6) 2018, a (b)(6)-year old female patient underwent stent graft placement to treat thoracic aortic aneurysm (taa) / abdominal aortic aneurysm (aaa).After another manufacturer's stent graft was placed below renal artery, touch-up ballooning was performed with coda balloon.The proximal platinum marker of the coda balloon was located at the proximal end of the stent graft during inflation.No part of the balloon was outside of the graft during inflation.At this point, the infrarenal abdominal aorta ruptured blood infusion was performed, but the patient's hemodynamic stability was not recovered.They attempted to place another stent graft was attempted to treat the abdominal aorta damage, but this attempt failed.Therefore, the procedure was converted to open surgical repair.The patient was not recovered, and deceased.As reported, the patient has severe calcification from the abdominal aorta through the iliac artery.The balloon was inflated using a 20cc syringe.However, the volume/pressure used during inflation is not known.It is not known if the patient was on anticoagulants.An autopsy will not be performed.The device will not be returned to aid in the investigation as the event was not related device defect.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the coda balloon device was not returned for an analysis and no photos or imaging were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed which includes a review of complaint history, the device history record, the instructions for use, manufacturing instructions, and quality control data.A review of the device history record (dhr) for lot 9088439 showed there were no non-conformances that would have caused or contributed to this incident.A complaint history records review revealed this is only reported complaint associated with complaint lot number 9088439.The complainant did not return the complaint device to cook for investigation.No autopsy report or imaging was provided.The volume used for inflation was not provided.It was reported there was severe calcification from the abdominal aorta through the iliac artery present.The physician also commented that ¿it is possible that the calcification within aorta and ballooning against stent graft may have impacted for aortic damage.¿ however, based on the available information, the definitive cause for the reported event cannot be determined.The appropriate cook personnel have been notified of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: CODA LP BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8126988
• Report Number: 1820334-2018-03465
• Device Sequence Number: 1913222
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)210813(10)9088439
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: G03831
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 9088439
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR