MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	81234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The implant or explant dates are not applicable to this device.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported during a therapeutic peripheral procedure, the image on the screen was flickering.The manufacture's catheter device was disconnected and reconnected; however, the image was poor.No other device was used to complete the procedure.No patient injury occurred.Visual and microscopic inspection and an image test were performed on the returned device.The distal tip was deformed.There was lifted adhesive at the distal fillet.A portion of adhesive from both the proximal and distal fillet was missing from the deep scratches.The probable cause of the missing adhesive could not be determined through the investigation.Strain, impact, and forces associated with use can affect the integrity of the device.It could not be determined how and when the cause of the failure occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because adhesive was missing from the device and it could not conclusively be determined when the separation occurred.There is a potential for harm if the malfunction were to recur.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.Internal reference: (b)(4).This follow-up supplemental report #1 is being submitted to report additional investigation findings, to wit: there is no potential for harm if the malfunction were to recur.This complaint was reassessed based on an engineering study that indicated, this family of catheters do not exhibit any adhesive detachment during normal use.There is no evidence of abnormal use conditions, it is likely the adhesive detached post-procedure, during the process of returning the device for analysis.There was no patient injury, no status decline, no adverse event, and no unplanned additional medical or surgical intervention reported.There is no potential for harm if the malfunction were to recur.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 h6: supplemental report #1 indicated that the adhesive likely detached post procedure; however, the conclusion code was not updated from 4315 (cause not established) to 4308 (cause traced to transport/storage).

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; alajuela B37 ; CS B37
• Manufacturer Contact: melissa pieplow ; 2870 kilgore road; rancho cordova, CA 95670 ; 9163651925
• MDR Report Key: 7917335
• Report Number: 2939520-2018-00110
• Device Sequence Number: 1399992
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(17)191231
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0259 50125399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 12/13/2021
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 03/04/2020; 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2017
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005