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

Model Number	014R
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3 & h6: the visions pv.014p rx catheter was not returned, 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.014p rx catheter was used in a therapeutic peripheral procedure in a moderately calcified distal pt.When the catheter was advanced to the lesion, resistance was encountered.The catheter was pulled back but got stuck on a non-philips guidewire; thus, was removed together.However, it was noticed that the distal portion of the catheter separated as it was coming out of the introducer sheath but was able to be removed.The procedure was completed with a new catheter.No patient injury reported.This product problem is being submitted because the visions catheter separated and was removed as a system.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h3: the visions catheter was returned without the non-philips guidewire.The catheter was returned without the distal section (includes portions of the distal shaft, inner member, trifilar, along with the distal tip and scanner).The proximal section (includes portions of the distal shaft and inner member, and core wire) that was returned, measured approximately 122.8 cm in length.Visual inspection found a tear from the exit port to the distal shaft.At the location of the separation, the core wire, microcables, and inner member were exposed, resulting in sharp edges observed.The overall catheter working length is 150 +/- 2.5 cm, which concludes that approximately 27.2 cm was not returned.Block h6: the probable cause of the shaft separation is due to use/handling.Strain, impact, and forces associated with use 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 21923178
• Report Number: 3008363989-2025-00054
• Device Sequence Number: 8713164
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)250227(17)270227(10)0303417788
• 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): 05/29/2025

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: 0303417788
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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: ABBOTT: 0.014", SPARTACORE GUIDE WIRE.; COOK: 6F, ANSEL INTRODUCER SHEATH.; PHILIPS: INTRASIGHT MOBILE CONSOLE.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American