MAUDE Adverse Event Report: VOLCANO CORPORATION REFINITY ST ROTATIONAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89900
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is brazil.Blocks h3 & h6: the refinity catheter was discarded, thus no returned product investigation was performed.Blocks h7, h9 & h10: 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 a refinity catheter was used in a coronary diagnostic procedure.During use, the catheter was unable to be removed from the philips guidewire (3008363989-2025-00074) independently; therefore, both were removed as a system.The procedure was completed with another device.No patient injury reported.This product problem is being submitted because the refinity catheter and philips guidewire were removed as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Blocks b5 & d10: additional information confirmed that the guidewire used with the refinity catheter was not manufactured by philips.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 a refinity catheter was used in a coronary diagnostic procedure.During use, the catheter was unable to be removed from the non-philips guidewire independently; therefore, both were removed as a system.The procedure was completed with another device.No patient injury reported.This product problem is being submitted because the refinity catheter and guidewire were removed as a system.There is potential for harm if it were to recur.

• Brand Name: REFINITY ST ROTATIONAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 22142801
• Report Number: 3008363989-2025-00073
• Device Sequence Number: 7276471
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)240620(17)260620(10)0303196629
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K160583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Expiration Date: 06/20/2026
• Device Model Number: 89900
• Device Catalogue Number: 89900
• Device Lot Number: 0303196629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .014 GUIDEWIRE, UNK MFG.; PHILIPS VOLCANO: CORE MOBILE SYSTEM.; PHILIPS: 0.014 GUIDEWIRE, MODEL UNK.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown