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

Model Number	89900
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
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.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.Sion blue, sion, guiding catheter(launcher).State/prefecture is (b)(6).Device has not been returned to the manufacturer for analysis.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
It was reported during a therapeutic coronary procedure the manufacturer¿s catheter device got stuck on a calcified lesion and could not be removed.The target lesion was lad [left anterior descending artery] with severe calcification and tortuosity.While the manufacturer¿s catheter device was manipulated to confirm stent landing, the tip of the device got stuck on a calcified lesion.Another manufacturer¿s wire device was inserted as a buddy-wire, a guideliner was inserted but only reached proximally due to calcium.The telescope shaft of the manufacturer¿s catheter device was cut and the transducer removed.Another manufacturer¿s wire device was inserted into the manufacturer¿s catheter device, freeing it for removal.The 2 wires and the manufacturer¿s catheter device were removed together.No portion of the device was left in the patient and no injury was reported.The procedure was continued and a balloon was used to dilate the lad, as planned.2 stents were implanted.Finally, ifr was used to evaluate.Another scheduled rca procedure was also completed with ifr assessment.This adverse event is being submitted because additional intervention was required to remove the manufacture's device.
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 h3: the device was visually and microscopically inspected and damage was observed.The outer telescope was broken and a portion missing.The proximal strain relief, the entire proximal and distal shaft and the distal tip were missing and not returned.The complete imaging core was exposed.It was inspected and no damage, no sharp or rough edges were detected.No portions were missing.Probable cause of the reported "stuck" complaint could not be determined as the returned device was incomplete.Probable cause of the damage to the device is damaged in use as the customer cut the 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.H3 other text : placeholder.
Event or Problem Description
This follow-up supplemental report #2 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).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the initial report submitted 05/28/2020 had an inadvertent entry error of (b)(6) 2020.Correct date is (b)(6) 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.
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: 10098372
• Report Number: 2939520-2020-00015
• Device Sequence Number: 14304636
• Product Code: OBJ
• UDI-Device Identifier: 00845225002831
• UDI-Public: (01)00845225002831(17)211130(10)0301800680(90)300003738791
• 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
• Report Date (Section B): 05/20/2020
• 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: 11/30/2021
• Device Model Number: 89900
• Device Catalogue Number: 400-0200.273
• Device Lot Number: 0301800680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• 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: 05/21/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 02/05/2021; 05/20/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/02/2020; 03/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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 Age: 84 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian
• Date Report Sent to FDA: 01/01/2005