MAUDE Adverse Event Report: VOLCANO CORPORATION CORE M2 VASCULAR SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	797411
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks a2-a5: no patient involvement.Blocks b6 & b7: no patient involvement.Block c: not applicable.Block d4: lot# and expiration date are not applicable.Blocks d6, d7, & d10: not applicable; no patient involvement.Blocks h3 & h6: the touchscreen monitor was not returned for evaluation, thus no returned product investigation was performed.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 or Problem Description
It was reported that the core m2 vascular system touchscreen monitor is cracked with sharp edges observed.There was no patient present and no user injury reported.This product problem is being reported in an abundance of caution because the touchscreen monitor has sharp edges that can result in a potential for harm.
Additional Manufacturer Narrative
Block h3: the touchscreen monitor was returned for evaluation.Visual inspection confirmed a crack, resulting in sharp edges.Block h6: based on the returned screen, the probable cause is likely due to unexpected damage from use.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.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: CORE M2 VASCULAR SYSTEM
• Common Device Name: 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 619633-4179
• MDR Report Key: 17821842
• Report Number: 3008363989-2023-00043
• Device Sequence Number: 6124783
• Product Code: IYO
• UDI-Device Identifier: 00845225012663
• UDI-Public: (01)00845225012663(11)200317(90)989609000151
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K170385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 797411
• Device Catalogue Number: 797411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown