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

Model Number	89900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks e1 & g2: country is japan.Blocks h3 & h6: the refinity catheter was not returned, thus no 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 therapeutic procedure in a moderately calcified lad.During pullback, slight resistance was encountered, and approx.30 cm from the distal tip separated.However, the separated portion remained intact to the non-philips guidewire and removed all together.The procedure was completed with a new refinity catheter with no patient injury reported.This product problem is being submitted because the refinity catheter shaft separated.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h3: the refinity catheter was returned without the distal section.The returned section includes the proximal shaft, portion of the distal shaft, drive cable, and the transducer, measuring approx.113.5 cm in length.At the location of the separation, the distal shaft was slightly stretched, the drive cable and transducer were exposed but still intact with no sharp edges observed.The distal section that was not returned includes the tip and portion of the distal shaft.The overall measurement spec is 135 +/- 1 cm, which concludes that approx.21.5 cm was not returned.Block h6: the probable cause of the reported failure is damage during use/handling.Strain, impact, and forces associated with use can affect the integrity of the device.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.
Additional Manufacturer Narrative
Additional information- block h3: the initial mdr stated that the distal section of the refinity catheter was not returned; however, this was received on 08jan2026.The distal section includes the tip and portion of the distal shaft, measuring approx.21.9 cm in length.There is no change to the investigation findings code, and imdrf# (b)(4)- fracture problem.Remains appropriate.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: 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 23767765
• Report Number: 3008363989-2025-00156
• Device Sequence Number: 10562705
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)241017(17)261017(10)0303313370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/14/2026

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: 89900
• Device Catalogue Number: 89900
• Device Lot Number: 0303313370
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/08/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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: 6F INTRODUCER SHEATH, MFG UNK.; ASAHI: 0.014", SION BLUE GUIDE WIRE.; NIPRO: 6F, PROFIT JL3.5ST GUIDE CATHETER.; PHILIPS: INTRASIGHT CONSOLE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian