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 02/12/2024

Event Type  Injury  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a4: 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 & h6: the visions pv.014p rx 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.014p rx catheter was used in a diagnostic peripheral procedure to treat the right iliac artery.The catheter was advanced through a 0.014" non-philips wire to interrogate the lesion in the aorta.During pullback, the transducer (tip) separated in the distal aorta, which probably got stuck on the fibrocalcific plaque.The separated portion was removed with a snare.Fluoroscopy and angiography confirmed no material was left inside the patient.The procedure was completed with a 0.018 ivus catheter.Patient was discharged with no complications or issues reported.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).

Manufacturer Narrative

Block h3: the visions pv.014p rx catheter was returned in two pieces.The separated distal portion (includes distal tip, distal and proximal fillet, scanner body, and a small portion of the distal shaft) was stretched and measured approximately 22 cm in length.The proximal portion (includes portion of the distal shaft, exit port, proximal shaft, luer, and connector) measured approximately 130.5 cm in length (total length is 152.5 cm).The overall catheter specification is 148-152 cm which concludes that no missing material was detected.The microcables and the core wire were broken and exposed with sharp edges observed.Block h6: the probable cause of the separated distal shaft is damage during use/handling.Strain, impact, and forces associated with use can affect the integrity of the device.Correction: based on device evaluation, the component code 3123- tip (initial mdr) was updated to 4721- rod/shaft.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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-406
• MDR Report Key: 18813355
• MDR Text Key: 336619334
• Report Number: 3008363989-2024-00015
• Device Sequence Number: 1
• Product Code: OBJ
• 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,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0303069148
• 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: 12/13/2023
• 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" HI-TORQUE COMMAND GUIDEWIRE; TERUMO: 6F INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Hispanic
• Patient Race: White