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

Model Number	88901
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.The visions pv.035 catheter was not returned for evaluation, thus no returned product investigation was performed.Blocks h7, h9 & h10: do not apply to this submission.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
It was reported that a visions pv.035 catheter was used in a diagnostic peripheral procedure.During use, the catheter had a poor image.Although venography and x-ray were used to complete the procedure, the patient will be brought back for ivus imaging of the compression area.No patient injury reported.This product problem is being reported because the catheter could not be used; resulting in a potential for harm due to the delay of the procedure.
Additional Manufacturer Narrative
Blocks a2, a3, a5, a6: patient date of birth, age at time of event, sex, gender, ethnicity, and race available.Block d10: concomitant medical products available.Block e4: updated from unk to no.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 b5: based on the device evaluation, this event has been determined as no longer reportable.Blocks d9 & h3: the visions pv.035 catheter was returned for evaluation.Block h3: visual inspection found no damage that could have led to the reported complaint of a poor image.During functional testing, the device was recognized by the laboratory core mobile system and produced a clear and constant image.Further, saline testing determined there was no evidence of fluid ingress on the distal and proximal fillets as the images remained clear.Block h6: based on the device evaluation, the reported complaint could not be confirmed as the device performed as intended.Therefore, the probable cause of the poor image experienced by the user could not be determined by the investigation.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
The initial mdr was reported for a poor image that the patient would be brought back for ivus imaging.However, based on the device evaluation, this is no longer reportable since the catheter produced and maintained a clear image.The catheter performed as intended; therefore, there is no potential for harm for delay of treatment with recurrence.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 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 kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 20931460
• Report Number: 3008363989-2024-00166
• Device Sequence Number: 8285837
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(11)240605(17)260605(10)0303214242
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 06/05/2026
• Device Model Number: 88901
• Device Catalogue Number: 88901
• Device Lot Number: 0303214242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 01/29/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: 0.035" J GUIDEWIRE, MFG UNK.; GUIDE WIRE, MFG AND SIZE UNK.; INTRODUCER SHEATH, MFG AND SIZE UNK.; PHILIPS: CORE MOBILE CONSOLE.; TERUMO, 10F INTRODUCER SHEATH.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White