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

Model Number	89900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Facility declined to provide patient information.The implant or explant dates are not applicable to this device.State/prefecture is (b)(6).Device has not been returned to the manufacturer for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer¿s policy.The customer reported during a planned therapeutic coronary procedure, the manufacturer's device could not be moved over another manufacture's guidewire.After stenting with another manufacture's device, the manufacturer's device was advanced to the place where stent was deployed and got stuck.An additional guidewire was inserted, then a balloon catheter and inflated.The manufacturer's device was released and removed as one-piece.This adverse event is being submitted because additional intervention was required to remove the manufacturer's device.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block h3: the incomplete device was visually and microscopically inspected, damage was observed.There is a portion of drive cable remaining inside the catheter shaft, sharp edges were observed on the exposed section of the drive cable where the physician reportedly cut the device.The probable cause of the reported ¿could not move¿ failure could not be determined due to the damaged stated of the returned device.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 the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to advise pertinent device analysis findings.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the initial report submitted 04/08/2020 had an inadvertent entry error of 03/18/2020.Correct date is 03/16/2020.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 the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in g4, the date received by manufacturer (becomes aware date).
Additional Manufacturer Narrative
Internal reference: (b)(4).Blocks b1 & b5: corrected from adverse event to both adverse event and product problem.
Event or Problem Description
This adverse event and product problem is being submitted because additional intervention was required to remove the manufacturer''s device.
Additional Manufacturer Narrative
Block g: the supplemental follow-up #2 submitted on 3/7/2021 had an inadvertent entry error of (b)(6) 2021.Correct date is (b)(6) 2020.

• Brand Name: REFINITY ROTATIONAL IVUS CATHETER, SHORT TIP
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 9941709
• Report Number: 2939520-2020-00012
• Device Sequence Number: 16337883
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)200430(10)0301430651(90)989609000981
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160583
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/16/2020
• Report Date (Section F): 01/01/2005

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: 04/30/2020
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0301430651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/17/2020; 02/05/2021; 08/24/2021; 03/16/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/24/2020; 03/07/2021; 08/24/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005