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	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a3b: not available from facility.Block b6: 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, thus no product evaluation 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 catheter was used during a therapeutic peripheral procedure in the distal sfa.During pullback, the catheter became stuck on the non-philips guidewire.To maintain access, the section of the guidewire that was outside of the patient was cut off, to remove the catheter and proximal portion of the guidewire together.The procedure was completed by delivering a new catheter over the remaining portion of the guidewire.No patient injury reported.This adverse event and product problem is being submitted because the visions catheter was entrapped, and additional intervention was required for removal.
Additional Manufacturer Narrative
Blocks d9 & h3: the visions catheter was returned for evaluation.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 the distal tip was deformed, the guide wire exit port was stretched; portions of inner member and distal shaft were bunched up, and micro cables were broken but not exposed.No functional testing performed due to the nature of the returned device.Block h6: the probable cause of the reported failure is damage during handling/use.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.
Additional Manufacturer Narrative
During further review of the overall complaint record, a discrepancy in the serial number was observed.Block d4: serial # corrected from (b)(6) to (b)(6).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
• MDR Report Key: 23588187
• Report Number: 3008363989-2025-00143
• Device Sequence Number: 9305211
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)250806(17)270806(10)0303545517
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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: 0303545517
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 01/29/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/24/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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: 0.014 ASTATO GUIDEWIRE; CORDIS: 6F INTRODUCER SHEATH; PHILIPS VOLCANO: CORE MOBILE SYSTEM
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian