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

Model Number	G03832
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: medtronic's endurant ii, gore dry-seal 14 fr introducer sheath.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 the coda balloon catheter was used to perform touch-up ballooning during an emergency endovascular aneurysm repair (evar) for rupture of an abdominal aortic aneurysm.As reported, the balloon ruptured during touch-up, so another device was used instead, and the procedure was completed with no problem.There has been no adverse effect to the patient reported.The implanted devices were from another manufacturer.There was no calcification present in the vessels containing grafts.Additionally the patient's anatomy was not tortuous but the neck was noted to be short.The inflation volume of the balloon when it ruptured cannot be determined, but appropriate volume and pressure were applied.Details on the balloons inflation cannot be provided but the user has a lot of experience using the coda balloon and he inflated the balloon as usual.An introducer sheath from another manufacturer was used with the balloon.The coda ruptured during ballooning in the proximal side of the main body graft from another manufacturer.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation and no photograph or imaging was 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, drawings, instructions for use, manufacturing instructions, and quality control data.The device history record was reviewed noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed no other complaints associated with the complaint device lot number 8749374.This device is shipped with the instructions for use (ifu) which states warnings, precautions and instructions for use.Balloons are inspected in quality control for damage and proper inflation.Balloon and fatigue design verification testing of the balloon show the device is capable of meeting design input requirements.Based on the information provided and without the complaint device the cause of this reported event could not be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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.
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: 7814413
• Report Number: 1820334-2018-02487
• Device Sequence Number: 2447490
• Product Code: DQY
• UDI-Device Identifier: 00827002038325
• UDI-Public: (01)00827002038325(17)210404(10)8749374
• 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,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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 Expiration Date: 04/04/2021
• Device Model Number: G03832
• Device Catalogue Number: CODA-2-9.0-35-100-32
• Device Lot Number: 8749374
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1