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

Model Number	014R
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Block b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3 & h6: the visions catheter was not returned for evaluation; thus, no 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 during a therapeutic peripheral procedure in the mid aorta.During the final ivus run, the catheter prolapsed/kinked and got stuck on the non-philips guidewire.The catheter was cut to remove from the patient.This adverse event and product problem is being submitted because the visions catheter was entrapped, and additional intervention was required to remove the device.
Additional Manufacturer Narrative
Block h3: the visions catheter was returned intact to a non-philips guidewire.Additionally, the catheter was in two pieces; however, it was intentionally cut in order to be removed from the patient.Visual inspection found a stretched guide wire exit port and proximal shaft with multiple bends present along the shaft.During functional testing, the guidewire could not be removed from the catheter.Block h6: the probable cause of the device entrapment is due to use/handling as evidenced by the damage observed.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: diana melliza galvez ; 3721 valley centre drive #500; san diego, CA 92130 ; 510933-4541
• MDR Report Key: 22081475
• Report Number: 3008363989-2025-00066
• Device Sequence Number: 9501563
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)250331(17)270331(10)0303444349
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0303444349
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: ASAHI: SION BLACK GUIDE WIRE, UNK SIZE.; BOSTON SCIENTIFIC: CATAPULT SHEATH, UNK SIZE.; PHILIPS: INTRASIGHT MOBILE CONSOLE.
• Patient Sex: Unknown