MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: information not provided.Block b6: information not provided.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions pv.018 catheter was not returned for evaluation, thus no returned product investigation was performed.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.

Event Description

It was reported that a visions pv.018 catheter was used in a diagnostic peripheral procedure in a calcified distal at.While passing through the lesion, the distal tip separated but remained intact to the non-philips guidewire.All parts were removed successfully.The procedure was completed with another catheter.No patient injury reported.This product problem is being submitted because the visions distal tip separated.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

Blocks d9 & h3: the visions pv.018 catheter was returned for evaluation.Block h3: the visions pv.018 catheter was returned in two pieces.The distal tip separated, measuring approx.9 mm (0.9 cm).The proximal portion of the distal tip that was intact to the catheter, measured approx.3 mm (0.3 cm).The returned device measured 135.7 cm from the luer to the location of the separation.The expected overall catheter is 135-139 cm in length.Block h6: the probable cause of the tip separation is damage during use/handling.Device manipulation, impact and applied pressure associated with use and handling can further 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 .018 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-406
• MDR Report Key: 19159431
• MDR Text Key: 341277993
• Report Number: 3008363989-2024-00024
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 0084360000037
• UDI-Public: (01)0084360000037(11)231102(17)251102(10)0303038976
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150442
• 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,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0303038976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• 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: ABBOTT: 0.014" COMMAND GUIDE WIRE.; PHILIPS: INTRASIGHT SYSTEM.; TERUMO: 5F SLENDER INTRODUCER SHEATH.