MAUDE Adverse Event Report: PHILIPS VOLCANO REFINITY CATHETER, SHORT TIP, 89900; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Embolism/Embolus (4438)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coronary procedure to treat an elevated st segment in the patient''s distal left circumflex artery (lcx) due to a thrombotic occlusion, a non-manufacturer''s balloon was used for pre-dilatation to establish blood flow from timi 0 to timi 3.A stent was placed across the artery, and due to ectasia of the proximal lcx, it was decided to do ivus to secure the size of the proximal part of the stent.A refinity ivus catheter was being prepared for use, but displayed no image.The refinity was disconnected and reconnected, but still no image.A second refinity catheter was opened, but also displayed no image, and re-attempted connection without success.Therefore, a third refinity catheter was opened and experienced the same failure.Finally, a fourth refinity catheter was opened and was able to be used; however, the overall attempt to perform ivus delayed the procedure approximately 15 minutes.The patient complained of chest pain and angiography showed a distal embolus (cause unknown) to the distal lcx, and thrombectomy was performed to re-establish blood flow from timi 0/1 to timi 3.This adverse event is being submitted to capture the fourth refinity catheter that was used in the patient which delayed the diagnosis and a distal embolus was observed requiring intervention.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Reporter source: country is (b)(6).Device evaluated by mfr: the refinity catheter was discarded by the facility, thus no returned product investigation was performed.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 CATHETER, SHORT TIP, 89900
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 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 yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 15342428
• Report Number: 3008363989-2022-00064
• Device Sequence Number: 5134522
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)220309(17)240309(10)0302545596
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 09/01/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302545596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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: GUIDEWIRE MFG AND SIZE UNK; INTRODUCER SHEATH, MFG AND SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male