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 Code	Vascular Dissection (3160)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic coronary procedure, the refinity catheter was loaded over a non-philips guidewire.During advancement in the lad, a dissection occurred; however, resolved itself without stent placement.The patient was transferred to the icu for monitoring, and discharged as expected.This adverse event is being submitted because a dissection occurred.There was no alleged malfunction with the refinity catheter.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Not applicable for this device.Implant or explant date: not applicable for this device.Report source: (b)(6).The refinity catheter was not returned for evaluation, 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.
Additional Manufacturer Narrative
Block h3/h6: the refinity catheter was returned for evaluation.Visual and microscopic inspection found no damage on the catheter.During functional testing, the device performed as intended.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
Additional information was obtained from the angiogram on 27mar2023: the angiogram shows the refinity catheter was not loaded onto a guidewire.The guidewire was extended into the vessel, but the catheter was clearly not placed over the guidewire.Therefore, the catheter did not follow the path of the guidewire, which likely caused/contributed to the dissection.
Additional Manufacturer Narrative
Block b5: additional information was obtained from the angiogram.Block h6: based on the information obtained from the angiogram, the cause of the dissection was due to use error.The ifu cautions: never advance the imaging catheter without guide wire support.The previous codes (investigation findings #213 and investigation conclusions #67) submitted in supplemental #1 remains applicable, as there was no damage found on the refinity catheter.The additional codes (#4248, #61, and #18) capture the use error.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: 15992245
• Report Number: 3008363989-2022-00080
• Device Sequence Number: 17551832
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(11)220624(17)240624(10)0302635498
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2023

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: 06/24/2024
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0302635498
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 12/06/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/17/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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: ASAHI: 0.014" GUIDEWIRE; CORDIS: 6F GUIDE CATHETER; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian