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

Model Number	89900
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a refinity catheter was used in a therapeutic coronary procedure in the mid circumflex artery.Prior to patient use, the catheter was flushed appropriately per the ifu.No air was observed and imaging was able to be completed.However, upon removal from the patient, air was present in the catheter.A new catheter was used to complete the procedure.No patient injury reported.This product problem is being reported for the air entrapped in the catheter.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks b6 & b7: no information available.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: 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
This product problem is no longer reportable because no air was seen entrapped in the device during the returned product evaluation.
Additional Manufacturer Narrative
Blocks b1/b5/h1: based on the returned product evaluation, this is no longer reportable for a product problem.There is no potential for harm since no air was entrapped in the catheter.Blocks d9 & g3: the refinity catheter was returned for evaluation.Block h3: visual inspection prior to decontamination, found no air observed inside the catheter.Post decontamination, the catheter was connected from the syringe to the one-way valve on the catheter hub with no issues.Without difficulty, the catheter was flushed twice continuously with no leaks from any location other than the vent port at the distal end of the monorail section (expected outcome).No presence of air was seen entrapped inside the catheter.Block h6: based on the evaluation, the catheter performed as intended.No air was entrapped in the catheter; thus, the reported complaint could not be confirmed.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 ROTATIONAL IVUS CATHETER ST
• 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 ; 719322-5355
• MDR Report Key: 18441081
• Report Number: 3008363989-2024-00001
• Device Sequence Number: 20800210
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)231003(17)251003(10)0303012518
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 10/03/2025
• Device Model Number: 89900
• Device Catalogue Number: 89900
• Device Lot Number: 0303012518
• 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: 01/03/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: BOSTON SCIENTIFIC: 0.014, GUIDEWIRE; MEDTRONIC: 6F LAUNCHER GUIDE CATHETER; TERUMO: 6F INTRODUCER SHEATH
• Patient Sex: Unknown