MAUDE Adverse Event Report: COOK INC CODA LP BALLOON CATHETER

Model Number	G03831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name and product code: catheter, percutaneous, dqy (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 (b)(6) male patient with a juxtarenal abdominal aneurysm underwent a fenestrated endovascular aneurysm repair (evar) on (b)(6) 2018.According to the report, while using the coda lp balloon catheter during graft placement, the resident tried to remove the balloon without fully deflating it.The balloon became stuck on the inside of the graft.There was mild angulation and calcification of the vessel.The balloon had to be further advanced to get it to detach from the graft.The balloon was successfully removed.Another graft limb was added in order to fix a junction leak that was created when the balloon was pulled while it was still inflated.No unintended portion of the device remained in the patient¿s body.There were no additional procedures required due to this occurrence.There were no adverse effects to the patient as a result of this event.
Additional Manufacturer Narrative
Adverse event additional information received.
Event or Problem Description
Additional information received.It was reported that imaging of the procedure is not available.The planning and sizing sheet is also not available.The resident appeared to be in a rush and did not confirm that the balloon was fully deflated before removing it from the graft.This did not appear to have anything to do with the coda balloon but was a technical failure by the operator.
Event or Problem Description
On august 8, 2018, additional information was received.The endoleak was fixed with another manufacturer's limb graft believed to be a 16mm x 10cm.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Concomitant medical products: g32542 - zfen-p-2-28-124-r.G32577 - zfen-d-12-62-76-c.G55233 - zsle-13-90-zt.G55234 - zsle-13-107-zt.Method codes: 4114, device not returned.Investigation ¿ evaluation.The complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and quality control data.The device history record was reviewed and no nonconformances related to the failure mode were noted.A complaint history review revealed this complaint to be the only complaint associated to complaint lot number 8778000.Each device is shipped with either an ifu t_coda2_rev1, t_coda46_rev0, t_coda_rev4, and t_codalp_rev1, which specifies the maximum balloon inflation volume and provides instructions on balloon preparation, inflation, deflation and withdrawal.According to the ifu the user is instructed to completely deflate the balloon using an appropriately sized syringe.Allow adequate time for the balloon to deflate.Deflate the balloon by pulling vacuum on the inflation syringe.This complaint focuses on a male patient who underwent an evar, it was reported that the balloon coda-2-9.0-35-120-32 (lot#:8778000) was used during a graft placement and the user tried to remove the balloon without fully deflating it.The balloon was advanced further to get it detached from the graft and then the balloon was successfully removed.Additional information was provided indicating that imaging is not available.The planning and sizing sheet is not available.The device was disposed of by the customer.The resident appeared to be in a rush and did not confirm the balloon was fully deflated before removing it from the graft.This did not appear to have anything to do with the coda balloon but was a technical failure by the operator.Based on the information provided with the complaint report, it is concluded that the user failed to follow instructions.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor 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 LP BALLOON CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7655621
• Report Number: 1820334-2018-01969
• Device Sequence Number: 156798
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)210417(10)8778000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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: 04/17/2021
• Device Model Number: G03831
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 8778000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/03/2018; 08/08/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 08/07/2018; 09/04/2018
• 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: 14 FR GORE DRY SEAL SHEATH LUNDERQUIST WIRE GUIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR