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

Model Number	89900
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint 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 e1 & g2: country is australia.Blocks h3: the refinity catheter has not been returned for evaluation, thus no returned product investigation was performed.Blocks h6: the user did not fully remove the air from the refinity catheter prior to use and flushed the catheter while inside the patient.The ifu warns that air entrapped in the catheter and flushing accessories can cause potential injury or death.Always verify that the catheter and flushing accessories have been properly cleared of air prior to inserting the catheter into the vasculature.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 a refinity catheter was used in a diagnostic coronary procedure in the mid circumflex artery.During prep, the catheter was flushed, connected to the pimr, then placed in the patient and ivus image showed air.The catheter was removed from the patient, flushed again, and placed back in the patient, but air was still present.At this point, the catheter was flushed while inside the patient and saw fluid escaping at the housing of the catheter.The catheter was removed and a new refinity 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.
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 found no unusual characteristics of the device.During functional testing, the catheter was connected from the syringe to the one-way valve on the catheter hub with no issues.The catheter was flushed twice continuously without difficulty and no leaks were observed from any location other than the vent port at the distal end in the monorail section (expected outcome).No air was seen entrapped in the device.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 ; 619633-4179
• MDR Report Key: 17550881
• Report Number: 3008363989-2023-00041
• Device Sequence Number: 17841824
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)230417(17)250417(10)0302880028
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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 Expiration Date: 04/17/2025
• Device Model Number: 89900
• Device Catalogue Number: 89900
• Device Lot Number: 0302880028
• 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: 08/15/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: ASAHI: 6F SION BLUE GUIDEWIRE; MEDTRONIC: 6F LAUNCHER EBU GUIDE CATHETER; TERUMO: GF INTRODUCER SHEATH
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White