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	12/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the refinity catheter was not returned for evaluation, 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 therapeutic coronary procedure in a severely calcified lad.Prior to use of the refinity, the artery was pre-dilated with a non-compliant balloon.After, the refinity was advanced over a wiggle wire; however, during pullback, the catheter got stuck in the lad.Attempts to remove via multiple techniques were unsuccessful; therefore, the refinity was cut from the pimr connection, and a guide liner catheter was advanced over the refinity to dislodge from the artery.The procedure was completed with ballooning and stenting.No patient injury reported.This adverse event and product problem is being submitted due to entrapment, requiring additional intervention.
Additional Manufacturer Narrative
Correction- block d1: brand name was corrected from "refinity rotational ivus catheter st" to "refinity st rotational ivus catheter" to align with gudid.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
Blocks d9 & h3: the refinity catheter was returned for evaluation.Block h3: the refinity catheter was returned without the connector and the inner telescope assembly.This aligns with the complaint details, where it states the pimr connection was intentionally cut during the attempt to remove from the patient.At the location where the connector was cut, braid metal and shaft material were exposed, with sharp edges observed.Visual inspection on the returned portion of the catheter found damage at the distal shaft and guide wire exit port.During functional testing, the catheter passed the guidewire movement test; however, resistance test could not be performed since the connector and the telescope were not attached.Block h6: the complaint details state the catheter got caught on the severely calcified lesion.However, the probable cause could not be established since the entirety of the catheter was not returned.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: 21200258
• Report Number: 3008363989-2025-00007
• Device Sequence Number: 18028508
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)241022(17)261022(10)0303318430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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
• Operator of Device: Health Professional
• Device Model Number: 89900
• Device Catalogue Number: 89900
• Device Lot Number: 0303318430
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 01/29/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/23/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: 7F INTRODUCER SHEATH, MFG UNK.; ABBOTT: WIGGLE GUIDE WIRE, SIZE UNK.; MEDTRONIC: 7F GUIDE CATHETER.; PHILIPS: INTRASIGHT CONSOLE.
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White