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

Model Number 014R

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported that a visions pv.014 rx catheter was used in a therapeutic peripheral procedure in the distal sfa.During removal, the catheter became stuck on the non-philips guidewire.The physician applied some degree of force in order to release, but the catheter separated near the rx exit port.The proximal portion of the catheter was removed, while the distal portion was intact to the guidewire and removed as a unit.X-ray and angiography confirmed that nothing was left in the patient.No patient injury reported.This product problem is being submitted because the visions catheter shaft separated inside the patient.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3: the visions pv.014p rx catheter was returned with only the distal portion, (includes distal tip, distal and proximal fillets, scanner body, and portion of distal shaft) which measured at approximately 11.2 cm from the distal tip to the separated location.Visual inspection found a damaged shaft and a bunched inner member.Additionally, the microcables were broken with sharp edges observed.The overall total working length is approximately 148-152 cm which concludes that approximately 138.8 cm of the proximal portion (includes portion of distal shaft, proximal shaft, luer connector, cable, and cable connector) was not returned.Blocks h6: based on the complaint details and the device evaluation, the probable cause of the reported failure is damage during use.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within the device.Blocks h7 & h9: 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.

• Brand Name: VISIONS PV .014P RX DIGITAL IVUS CATHETER
• Type of Device: 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 ; 619633-417
• MDR Report Key: 17887199
• MDR Text Key: 325121884
• Report Number: 3008363989-2023-00046
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(10)230419(17)250419(10)0302883582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0302883582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO: 0.014 GLIDEWIRE ADVANTAGE; TERUMO: 6F DESTINATION INTRODUCER SHEATH