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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIREME MEDICAL LLC CHOCOLATE XD PTCA BALLOON CATHETER

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TRIREME MEDICAL LLC CHOCOLATE XD PTCA BALLOON CATHETER Back to Search Results
Model Number CX14-140-3015 RX
Device Problem Separation Problem (4043)
Patient Problem Death (1802)
Event Date 03/11/2020
Event Type  Death  
Manufacturer Narrative
The product was returned to vsi on 03/17/2020. Considering the recent events pertaining to covid-19, product inspection is paused and will not be evaluated at this time. The manufacturing record review was completed and no related nonconformances were found, supporting the device met material, assembly and performance specifications. A follow-up report will be submitted when product return investigation is completed.
 
Event Description
It was reported that the physician inserted a chocolate 3. 0x15 balloon into mid cirx proper in-stent stenosis and dilated twice at 10atm then 14atm. While removing the chocolate balloon, it hung up in the proximal left system and it was difficult to remove. The physician placed another balloon parallel to release the chocolate and remove, but when they tried to remove the chocolate, the shaft broke, leaving the distal balloon portion in the left main. No further complications were reported. Additional information received 17mar2020: the patient was not hemodynamically unstable prior to chocolate use. There were proximal existing stents that seem to have caught the chocolate balloon, a cirx stent that extended proximally to left main. The angle was acute at cirx take off from left main to suggest tortuosity. The chocolate was inflated twice 10atm then 14atm in mid cirx lesion and met resistance while removing when encountering tight, stented bend of proc cirx/lm. The patient was stable when the procedure ended. The ic commented the patient wasn't having ischemia. The patient had a closure device, sheath was removed, and patient was transferred to room in hospital. There was flow in the left system. Act was over 300 and timi flow i would guess timi 2. Requested additional information including cause of death, and date of death multiple times. No further information has been received at this time.
 
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Brand NameCHOCOLATE XD PTCA BALLOON CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
TRIREME MEDICAL LLC
7060 koll center parkway
suite 300
pleasanton, ca
Manufacturer (Section G)
TRIREME MEDICAL LLC
7060 koll center parkway
suite 300
pleasanton, ca
Manufacturer Contact
shiva ardakani
7060 koll center parkway
suite 300
pleasonton, ca 
9311300
MDR Report Key9941754
MDR Text Key187015042
Report Number3008089360-2020-00001
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberCX14-140-3015 RX
Device Lot NumberF1904295000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/08/2020 Patient Sequence Number: 1
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