MAUDE Adverse Event Report: VOLCANO CORPORATION VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 400-0100.01

Device Problem Inappropriate Waveform (2536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: no information available.Blocks b6-b7: no information available.Block c: not applicable for this device.Blocks d4 & d6 & d7: not applicable for this device.Blocks h3 & h6: the field service engineer replaced the ffm pim module and the extender cable on the core mobile system at the customer site.The system met specification for the performed service and returned for use.Blocks h7 & h9: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that a core mobile system was used in a non-emergency coronary left heart catheterization procedure.The patient was prepped with local anesthesia, and in the middle of the procedure, the system malfunctioned.The waveforms did not overlap as expected; therefore, the physician decided to abort the procedure.There was no patient injury reported.The plan was to send the patient to another hospital for treatment.This adverse event and product problem is being reported because the patient was fully prepped, and the system stopped mid procedure.This resulted in a delay of the procedure.

Manufacturer Narrative

Block h3: the core mobile ffr pimmette was returned for evaluation without the extender cable (ffr pimmette and extender cable replaced at facility site).Visual inspection of the ffr pimmette found no damage observed.During functional testing, the ffr pimmette was connected to the lab system and was able to be recognized by the system.The device functioned as expected with a pressure wire simulator, even upon manipulation of the cable connection and disconnection/reconnection of the ffr pimmette to the system.Block h6: based on the returned device evaluation, the probable cause of the reported failure could not be conclusively determined since the device functioned as intended.However, the extender cable was not returned for evaluation; therefore, the cause of the reported failure could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-406
• MDR Report Key: 18162666
• MDR Text Key: 328430811
• Report Number: 3008363989-2023-00058
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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 Model Number: 400-0100.01
• Device Catalogue Number: 400-0100.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Other