MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER 2; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	88901
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.No tests/laboratory data was available.The implant or explant dates are not applicable to this device.Per the ifu precautions: do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.If binding occurs outside of the patient, remove the catheter and do not use; the catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis; if resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported, the manufacturer's device was plugged in and a black screen was displayed.No image was displayed.Another catheter was used to complete the procedure.The manufacturers device was being used for peripheral diagnostic imaging.Visual and microscopic inspection and an image test were performed on the returned device.The device was connected to the lab imaging system and produced a proper image.No error occurred upon manipulation of the scanner body.Both proximal and distal fillets had scratches.Rotation force was applied on the distal tip.Twisting between the scanner body and the distal tip was observed within the adhesive on the distal fillet.There were indications of missing fillet material on both the distal and proximal ends of the scanner body.The device produced and maintained a clear, proper image with the imaging system.As a result, the probable cause could not be determined.There was missing adhesive at both the distal and proximal fillets.The probable cause of the missing adhesive is damage in use, likely scratched away as it passed through a tight occlusion, as evidenced by the scratch marks observed on the scanner and uv fillets.Strain, impact, and forces associated with use can affect the integrity of the device.It could not be conclusively determined when the cause of the missing adhesive occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This event is being reported as there is a potential for harm if the malfunction were to recur.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER 2
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7708982
• Report Number: 2939520-2018-00071
• Device Sequence Number: 789859
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(17)200430(10)0301430795(90)989609000491
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 04/30/2020
• Device Model Number: 88901
• Device Catalogue Number: 400-0200.173
• Device Lot Number: 0301430795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1