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

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.

Manufacturer Narrative

A returned product evaluation was completed.The distal assembly, from the rapid exchange (rx) port forward to the distal tip was separated.Elongation (necking) of the polymer lumen at the distal end was present indicates that significant tensile load was applied during clinical use.The failure occurred in the mid-extrusion portion, not at or near the designed catheter bond.The 20cm (approximate) section of separated catheter was not returned.The root cause of the failure is related to user error.

• Brand Name: CHOCOLATE XD PTCA BALLOON CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): TRIREME MEDICAL LLC; 7060 koll center parkway; suite 300; pleasanton, ca
• MDR Report Key: 9941754
• MDR Text Key: 187015042
• Report Number: 3008089360-2020-00001
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00818472012175
• UDI-Public: (01)00818472012175
• Combination Product (y/n): N
• PMA/PMN Number: K153682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: CX14-140-3015 RX
• Device Lot Number: F1904295000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 105