MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .014P RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	014R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a4: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions catheter was not returned to the manufacturer 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.014 rx catheter was used in a peripheral therapeutic procedure.During pullback from the right common femoral to the right common iliac, the distal tip separated but remained intact to the non-philips guidewire.At this time, there was no attempt to remove from the patient.Instead, a rx balloon was loaded from the post tibial artery, then pushed up to the right iliac to accomplish the angioplasty.Afterwards, both the catheter and guidewire were removed as a system.The case was completed with no patient injury reported.This product problem is being submitted because the visions distal tip separated; potential for harm.
Additional Manufacturer Narrative
Blocks d9 & h3: the visions pv.014p rx catheter was returned for evaluation.Block h3: the visions pv catheter was returned in two pieces with the distal section stuck on a guidewire.The distal section includes the tip, fillet, and scanner body; measuring approx.1.4 cm in length.The proximal section includes a portion of the scanner body, shaft, luer, cable connector, and connector; measuring approx.148.8 cm in length.The total working length combined is 150.2 cm, which is within specification of 147.5-152.5 cm.Visual inspection found a bent scanner body, and at the location of the separation, the kapton was lifted, exposing the die, unibody, and backing material; resulting in sharp edges observed.Block h6: the probable cause of the separation is damage during use/handling of the device.Strain, impact, and forces associated with handling can affect the integrity of 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 an alleged death or deterioration in the state of the health of any person.

• Brand Name: VISIONS PV .014P RX 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 21368546
• Report Number: 3008363989-2025-00017
• Device Sequence Number: 18252149
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)241128(17)261128(10)0303352063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152829
• 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
• Report Date (Section B): 03/07/2025

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 Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0303352063
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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: ASAHI: 0.014 MONGO ES GUIDE WIRE; PHILIPS VOLCANO: CORE M2 SYSTEM; TERUMO: 7F DESTINATION INTRODUCER SHEATH
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White