MAUDE Adverse Event Report: EMERALD MEDICAL SERVICES PTE LTD CHOCOLATE XD PTCA BALLOON CATHETER

Model Number CX14-140-3010 RX

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2022

Event Type  Death  

Manufacturer Narrative

Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.

Event Description

As reported: the chocolate xd balloon was inflated in the om branch of the circumflex artery to dilate a calcified in-stent restenosis.The balloon was deflated and upon removal, the cage was lodged in the vessel.When it was pulled back the balloon and nitinol cage were separated from the shaft.Every interventional attempt was made to remove the device (snares, aspiration, guide extension).The device was unable to be retrieved from the vessel.The patient became unstable and required ecmo support.Additional information on 06 sept 2022: the patient is still on ecmo, intubated and in the icu.Patient's current condition is reported as serious.The patient received cpr and was intubated and ventilated due to this event.

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.Case details were reviewed.A patient underwent a pci procedure.Customer stated that the chocolate balloon was inflated in the om branch of the circumflex artery to dilate a calcified in-stent restenosis.The balloon was deflated and upon removal, the cage was lodged in the vessel.When pulled back, the balloon and nitinol cage were separated from the shaft.Additional information was requested.A response was received.Patient was intubated and ventilated due to this event.Cpr and extracorporial membrane oxygenation (ecmo) were performed.Limited still frames excerpted from the original angiograms were provided.These images, in isolation, are not interpretable with respect to the sequence of events during the procedure, or angiographically-evident complications that may have contributed to the patient outcome.However, a deployed stent is noted immediately beyond the origin of an om branch.This stent is presumed to be the restenotic device that was the target for therapy.Without provision of the original diagnostic and pci cine angiograms in full resolution format, and accompanied by a full procedural log or report, no further inferences or conclusions are possible.A picture of the device was reviewed.The polymer appears to be stretched and torqued which, is indicative of operation against resistance.The distal section of the device does not appear to be the point where the distal cage separated due to the following reasons: i.The blue polymer tubing which is present on both proximal and distal to the balloon & cs (nitinol constraining structure) is missing.Ii.The metallic lumen (inner mesh/braid structure) in which the balloon polymer and nitinol cage sits is missing.Iii.An in-house device was reviewed and compared to the picture sent by the account.The transparent polymer is closely aligned with the rx port.Therefore, this can imply that the shaft separated at approximately 25 cm from the distal tip.The supplier of chocolate was notified of the complaint.A manufacturing record review was completed and no nonconformances were found.The supplier reviewed the pictures and stated the following: the entire distal shaft section is not present in the photo, this includes the balloon and cs the inner membrane is not present in the photo the rx bond is not present in the photo, this is the section distal to the rx port.The intermediate shaft is present and has stretched proximal to the break.The intermediate shaft joins the proximal hypotube to the distal section.The images indicate the cs/balloon section may be within the in-stent stenosis.It appears the unit became detached just distal to the rx port (on the intermediate shaft).Since the intermediate shaft exhibited stretching, it appears that the distal section must have been "stuck" or caught on something causing resistance to withdrawal of the device.Failure mode was replicated with a pull tester as the test apparatus to perform withdrawal with the distal section secured in place.The pull test was performed, and it was found that the intermediate shaft stretched and detached just distal to the rx port, which is similar to the condition of the complaint unit in the photographs we were provided by the customer.Based on our current information, it is likely that the chocolate cage interacted with the stent strut during deflation causing it to not deform back to its original state, and resulting in the distal section being "stuck," and causing resistance to the withdrawal of the device further manipulation could have led to the separation of the shaft.It also is possible the shaft could have been stretched leading to the separation as a result of the attempts to pull it out during the cpr.Evidence of the polymer being stretched can be seen in the picture sent by the account.Ifu was reviewed, and the following was noted: indication: the chocolate xd® ptca balloon catheter is intended for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.Contraindication: crossing through stent struts.Warnings: the chocolate xd® ptca balloon catheter has not been tested for post-dilatation of stents, advancement through stent struts or synthetic vascular grafts and should not be used under such conditions.Chocolate xd® ptca has not been tested for vessels that have multiple stents or more than a single layer of metal and should not be used under such conditions.Balloon pressure should never exceed the rated burst pressure (rbp).Exceeding the rbp may result in balloon rupture and cs failure.The catheter should be used under fluoroscopic guidance.Do not advance or retract.The catheter unless the balloon is fully deflated under vacuum.Do not advance against resistance.Without first determining the cause of the resistance and taking appropriate action procedure (step 5 of positioning and deployment): advance the dilatation catheter over the guidewire and to the stenosis.Use the radiopaque markers on the balloon for positioning.Note: do not advance against resistance.When resistance is felt while crossing the lesion, slightly pull back the catheter and try to advance again.If resistance persists, do not force passage.Account confirmed the patient died.Additional information on medical records, autopsy report, and reported cause of death was requested.No response was received.Per ifu, death, coronary artery dissection or perforation, emergency percutaneous coronary intervention are identified as some of the potential adverse effects that may result from balloon dilation procedure.Based on our investigation, the root cause of the nitinol cage lodging in the vessel and the balloon and nitinol cage separating from the shaft, was resistance from the distal tip being "stuck" (most likely as a result of interaction with the stent strut) and the application of force in an attempt to withdraw the device.There is no evidence of any malfunction or non-conformity in the device that was the root cause of the reported event.

• Brand Name: CHOCOLATE XD PTCA BALLOON CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): EMERALD MEDICAL SERVICES PTE LTD; 8, admiralty street; #06-16 admirax building; singapore 75743 8; SN 757438
• Manufacturer (Section G): EMERALD MEDICAL SERVICES PTE LTD; 8, admiralty street; #06-16 admirax building; singapore 75743 8; SN 757438
• Manufacturer Contact: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 15411155
• MDR Text Key: 299777182
• Report Number: 3008089360-2022-00001
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 10841156105464
• UDI-Public: 10841156105464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CX14-140-3010 RX
• Device Catalogue Number: CX14-140-3010 RX
• Device Lot Number: 1046953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG