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

Model Number	89900
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Chest Pain (1776); Restenosis (4576)
Date of Event	08/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Foreign source: country is denmark.The refinity catheter was not returned for evaluation, thus no returned product investigation was performed.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 during a coronary procedure to treat an elevated st segment in the patient''s left anterior descending (lad), a non-manufacturer''s balloon was used for pre-dilatation to establish blood flow from timi 0 to timi 3.Then, a refinity ivus catheter was being prepared for use to measure the diameter of the vessel for stent placement, 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.After approximately 15 mins, and while attempting to use the third refinity catheter, the patient complained of chest pain and the ecg showed re-elevation of the st segment.Angiography showed re-occlusion of the vessel.The vessel was pre-dilated and timi 3 flow was re-established.The procedure was completed with a non-manufacturer¿s ivus guided stent.This adverse event and product problem is being submitted to capture the third malfunctioning refinity catheter (not used in patient), which delayed the diagnosis and resulted in re-occlusion of the vessel, requiring intervention.
Additional Manufacturer Narrative
Block h3: the refinity catheter was returned for evaluation.Visual inspection found a portion of the drive cable exposed and a portion of the shaft was stretched and broken.No missing material was detected.Image verification test could not be performed due to the damage observed on the catheter.Block h6: the probable cause of the reported failure "no image" could not be conclusively determined since the catheter was received damaged.It is unknown when the damaged occurred; therefore, the cause could not be established.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: 15342427
• Report Number: 3008363989-2022-00063
• Device Sequence Number: 5134521
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)220606(17)240606(10)0302619738
• 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,Followup
• Report Date (Section B): 09/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2024
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302619738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male