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 08/31/2023

Event Type  Injury  

Event Description

It was reported that a visions pv.018 catheter was used in a therapeutic peripheral procedure in the proximal brachial artery.During removal, the catheter distal tip separated in the left basilic vein of the fistula and required removal with a snare.There was no resistance or force applied during pullback, and no calcification or scar tissue noted in this area.X-ray confirmed no piece was retained inside the patient.The patient was discharged after post care with no injury reported.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a4-a5: no information available.Block b6: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the visions pv.018 catheter was returned with only the proximal portion (includes catheter shaft, luer, connector, and cable connector) which measured at approximately 136 cm from the luer to the location of separation.Visual inspection found a stretched expanded single lumen and a zipper tear from the guide wire exit port to the location of separation.Additionally, the microcables were broken and exposed with sharp edges observed.The overall catheter working length is approximately 135-139 cm which concludes that approximately 1.6 cm of the distal portion (includes distal tip, distal fillet, scanner body, and section of the expanded single lumen) was not returned.Block h6: although the complaint details state that no force or resistance was encountered, this does not align with the device evaluation based on the damage observed.Therefore, the probable cause of the reported failure is damage during removal/handling of the catheter.Strain, impact, and forces associated with handling can affect the integrity of 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 .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: 17881012
• MDR Text Key: 325035734
• Report Number: 3008363989-2023-00045
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)230417(17)250417(10)0302881578
• 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
• Report Date: 10/05/2023

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
• Device Operator: Health Professional
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0302881578
• 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: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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: ASAHI: 0.018" GLAIDUS GUIDEWIRE; CORDIS: 6F BRITE TIP 5.5CM INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male