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

Model Number	G03831
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 the balloon broke off the shaft.They were ballooning a loim during an endovascular aortic repair (evar) case.Maybe wasn't fully deflated while being pulled back into the sheath, tore off.Balloon was left in patient and covered with a stent, shaft is available for return.Had to cover a vessel with stent placement that wasn't originally planned to be covered.Additional information received clarified that the surgeon was balloon molding the limb at the end of the case and while trying to pull it back into the sheath it got stuck.The area where the ballooning was being done was mid to distal end of the zenith spiral-z aaa iliac leg graft in patient¿s left iliac just above the hypogastric.While trying to pull the balloon into sheath it broke off halfway in zenith spiral-z aaa iliac leg graft limb and half in native common femoral covering hypogastric.The coda did not burst.It is thought that it was sheared off by the sheath that had been inserted and removed from the patient several times and was coming in at a sharp angle due to iliac tortuosity.The balloon was deflated but possibly not completely.The decision was made to leave the device portion inside the patient because the balloon was stuck (we think probably at the tip of the sheath or somehow stuck on the stent body at the distal end of the zenith spiral-z aaa iliac leg graft) and the surgeon had to pull hard to dislodge it.At this point the shaft came out without the balloon part.No other interventions were made.Surgeon felt strongly that it was stuck on something and a snare would not be strong enough to pull it out.Patient had a lot of fluoroscopy time and was already in a wheelchair.There was some calcification but not at the spot where the balloon broke and there was a reasonable amount of tortuosity in the patient's iliac arteries.An excluder limb was used to lock the balloon in place and covered left hypo.
Event or Problem Description
There has been no new information received since the last report was submitted.
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.No photographs or imaging was provided for review.A document based investigation was conducted including a review of complain history, the device history record, drawings, instructions for use, and quality control data.A review of the device history record found there were no non-conformances detected.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 9073971.The instructions for use (ifu) states the following in consideration of the reported failure mode: balloon preparation.Note: balloon and balloon lumen of the coda and the coda lp balloon catheters contain air.The air must be removed from balloon and balloon catheter prior to insertion using standard technique.1.Remove protective balloon sleeve.2.Prepare balloon lumen with standard 3:1 saline and contrast mixture as follows: a.Attach syringe, with appropriate amount of 3:1 saline and contrast mixture, to stopcock on balloon lumen.B.Purge all air from balloon in standard fashion.C.Completely deflate balloon and close stopcock.3.To increase ease of insertion, balloon may be lubricated with a thin layer of sterile, biocompatible lubricant.Balloon introduction and inflation.1.Flush the distal lumen using heparinized saline solution.2.Advance the balloon catheter over a pre-positioned.035-inch wire guide, utilizing a minimum 14.0 french introducer sheath for the 10.0 french coda balloon catheter or a minimum 12.0 french introducer sheath of the 9.0 french coda lp balloon catheter.Note: if resistance is met while advancing the wire guide or balloon catheter, determine the cause and proceed with caution.Caution: prior to introduction, determine the amount of standard 3:1 saline and contrast mixture needed to inflate the balloon to the desired inflation diameter.Refer to the balloon inflation parameters chart in fig.1.Over-inflation of the balloon may result in damage to vessel wall and/or vessel rupture.3.Under fluoroscopy, advance the balloon to the desired position using radiopaque markers.Caution: if the coda or coda lp balloon catheter is being utilized to expand a vascular prosthesis, use the radiopaque markers to ensure that the entire balloon is positioned within the prosthesis.4.Inflate balloon with standard 3:1 saline and contrast mixture using a 20 cc or larger syringe.Adhere to recommended balloon inflation volumes.5.If balloon pressure is lost and/or balloon rupture occurs, deflate the balloon and remove balloon and sheath as a unit.Note: care should be taken to monitor balloon manipulations an inflation using fluoroscopy at all times.Cook was unable to perform a physical evaluation on the complaint device as the product was not returned.There is no imaging or sizing information.There is no information regarding the sheath size used in this procedure.A definitive conclusion could not be established as the product was not returned in order to gauge the physical state of the device to see if there were any defects, deformities, or damages that could have potentially contributed to the balloon breaking off the shaft.However, because the customer indicated that the balloon was deflated but possibly not completely, the most likely cause of failure could be attributed to improper use-error in insertion/withdrawal of the balloon catheter into/out of the patient.Specifically, the balloon being removed from the graft without being deflated fully, leading to the balloon manifold snagging on object inside the patient requiring undue force to be able to withdraw intact and thus causing balloon separation.There is the possibility that the device may not have completely deflated due to an occlusion in the balloon lumen.A balloon lumen occlusion can be attributed to contrast dye drying in the lumen.The physician did state the patient had ¿a lot of fluoroscopy time¿.Based on the test summaries reviewed, in particular, the tensile evaluation of the over-molded manifold to shaft bond which ensures each manifold to shaft bond should have a maximum load greater than 15n, there is adequate testing to assure that the balloon-to-shaft bond is sufficient to withstand forces experienced during the procedure.Based on the information available, the investigation conclusion is the cause cannot be traced to the device; the adverse event is related to the procedure.Per the quality engineering risk assessment, no further action is warranted.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.

• 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: 8090014
• Report Number: 1820334-2018-03085
• Device Sequence Number: 16503127
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)210807(10)9073971
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: G03831
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 9073971
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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: Required Intervention
• Patient Age: 81 YR